🔍 RecallPedia

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.

Class I - Dangerous
🏥 Medical Devices Recalled: September 30, 2025 Medline Industries Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    1) CDS840261AB: UDI/DI 10195327104535 (each), 40195327104536 (case), Lot Numbers: 23FBF165, 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each), 40195327228126 (case), Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each), 40195327327829 (case), Lot Numbers: 23FBA013, 23FBH486, 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Numbers: 23GBT133, 23HBH924, 23HBL135, 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each), 40193489288606 (case), Lot Numbers: 23KBU348, 24ABB883, 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each), 40195327357284 (case), Lot Numbers: 23GDB197, 23GDB757. 7) DYNJ0421380P: UDI/DI 10195327084271 (each), 40195327084272 (case), Lot Numbers: 23DMI590, 23FMJ656. 8) DYNJ21877W: UDI/DI 10195327104542 (each), 40195327104543 (case), Lot Numbers: 23FBT682, 23GBF898, 23IBC645, 24ABR316. 9) DYNJ22350L: UDI/DI 10193489445251 (each), 40193489445252 (case), Lot Numbers: 23LBU055, 24BBQ300. 10) DYNJ27432AC: UDI/DI 10195327104511 (each), 40195327104512 (case), Lot Numbers: 23EBU150, 23GBF873, 23HBQ650, 23IBB637. 11) DYNJ37284K: UDI/DI 10195327401030 (each), 40195327401031 (case), Lot Numbers: 23IBP124, 23KBF938, 24ABS487. 12) DYNJ38175L: UDI/DI 10195327227906 (each), 40195327227907 (case), Lot Numbers: 23FLA915, 23ILA168. 13) DYNJ42921G: UDI/DI 10193489981384 (each), 40193489981385 (case), Lot Numbers: 23FBU282, 23IBT172. 14) DYNJ43207K: UDI/DI 10193489952926 (each), 40193489952927 (case), Lot Numbers: 23EME962. 15) DYNJ43214F: UDI/DI 10193489953077 (each), 40193489953078 (case), Lot Numbers: 23EMA158. 16) DYNJ44847I: UDI/DI 10195327127558 (each), 40195327127559 (case), Lot Numbers: 23HLA758, 23HLB101, 23LLA759. 17) DYNJ44857U: UDI/DI 10195327298067 (each), 40195327298068 (case), Lot Numbers: 23GBI967, 23GBQ950. 18) DYNJ44869K: UDI/DI 10195327127657 (each), 40195327127658 (case), Lot Numbers: 23GBI967, 23GBQ950, 23KMC104. 19) DYNJ44879K: UDI/DI 10195327282233 (each), 40195327282234 (case), Lot Numbers: 23DBI854, 23EBH319, 23GBT541. 20) DYNJ44886M: UDI/DI 10195327127749 (each), 40195327127740 (case), Lot Numbers: 23DBN895, 23EBU129, 23FBQ134, 23GBQ953, 23HBT951. 21) DYNJ50528M: UDI/DI 10195327129699 (each), 40195327129690 (case), Lot Numbers: 23EBA780, 23EBS770, 23GBT274. 22) DYNJ51038R: UDI/DI 10195327298258 (each), 40195327298259 (case), Lot Numbers: 23HBD834. 23) DYNJ56838F: UDI/DI 10195327277857 (each), 40195327277858 (case), Lot Numbers: 23GDA228, 23HDA839. 24) DYNJ56839D: UDI/DI 10195327277864 (each), 40195327277865 (case), Lot Numbers: 23GDA320. 25) DYNJ60548B: UDI/DI 10195327361761 (each), 40195327361762 (case), Lot Numbers: 23EBD777, 23IBS545, 23JBJ740. 26) DYNJ60783B: UDI/DI 10195327361846 (each), 40195327361847 (case), Lot Numbers : 23EBR616, 23GBW384, 23IBV398. 27) DYNJ61659A: UDI/DI 10193489929638 (each), 40193489929639 (case), Lot Numbers: 23HBI627. 28) DYNJ62097C: UDI/DI 10195327189839 (each), 40195327189830 (case), Lot Numbers: 23DBJ117, 23EBD473, 23HBQ663, 23IBB641. 29) DYNJ65039C: UDI/DI 10195327528256 (each), 40195327528257 (case), Lot Numbers: 24BMF955, 24CMB409, 24CME382, 24FMH176. 30) DYNJ66033B: UDI/DI 10195327680589 (each), 40195327680580 (case), Lot Numbers: 24EBA176. 31) DYNJ80609D: UDI/DI 10195327298296 (each), 40195327298297 (case), Lot Numbers: 23HBR318, 23HBZ183. 32) DYNJ81581B: UDI/DI 10195327379254 (each), 40195327379255 (case), Lot Numbers: 23EBO537, 23GBQ499, 23HBG425. 33) DYNJ81605: UDI/DI 10195327123888 (each), 40195327123889 (case), Lot Numbers: 23DBL829, 23EBI374, 23EBM656. 34) DYNJ81610B: UDI/DI 10195327398316 (each), 40195327398317 (case), Lot Numbers: 23EBA748, 23IBP506. 35) DYNJ82166: UDI/DI 10195327182564 (each), 40195327182565 (case), Lot Numbers: 23FDA955. 36) DYNJ82217: UDI/DI 10195327183585 (each), 40195327183586 (case), Lot Numbers: 23DDB931, 23HDA667. 37) DYNJ84017B: UDI/DI 10198459253089 (each), 40198459253080 (case), Lot Numbers: 25CMF132. 38) DYNJ85109: UDI/DI 10195327460594 (each), 40195327460595 (case), Lot Numbers: 23JBD986. 39) DYNJ85110: UDI/DI 10195327460792 (each), 40195327460793 (case), Lot Numbers: 23KBF140. 40) DYNJ85118: UDI/DI 10195327460730 (each), 40195327460731 (case), Lot Numbers: 23KBI277. 41) DYNJ85121: UDI/DI 10195327460853 (each), 40195327460854 (case), Lot Numbers: 23IBR236, 23JBC564. 42) DYNJ85637: UDI/DI 10195327528188 (each), 40195327528189 (case), Lot Numbers: 24CBL150. 43) DYNJ900293K: UDI/DI 10195327554064 (each), 40195327554065 (case), Lot Numbers: 24ABE610, 24BBT270, 24DBU219. 44) DYNJ900714C: UDI/DI 10193489951363 (each), 40193489951364 (case), Lot Numbers: 23FBL767, 23HBW562, 23JBF697. 45) DYNJ901066K: UDI/DI 10195327239282 (each), 40195327239283 (case), Lot Numbers: 23HBB464, 23HBC020, 23JBF553, 23JBW634. 46) DYNJ903042P: UDI/DI 10195327438388 (each), 40195327438389 (case), Lot Numbers: 23JBL424, 23LBL094, 24ABS138. 47) DYNJ905079F: UDI/DI 10195327209001 (each), 40195327209002 (case), Lot Numbers: 23GBV464, 23HBO354. 48) DYNJ905497B: UDI/DI 10193489951639 (each), 40193489951630 (case), Lot Numbers: 23GBB505, 23HBN192, 23JBV542, 23JBV684. 49) DYNJ906175B: UDI/DI 10195327480127 (each), 40195327480128 (case), Lot Numbers: 24FMI570. 50) DYNJ907105D: UDI/DI 10195327233624 (each), 40195327233625 (case), Lot Numbers: 23EBG144, 23EBT013, 23FBI805, 23FBQ992. 51) DYNJ907904A: UDI/DI 10193489992434 (each), 40193489992435 (case), Lot Numbers: 23JME513, 23KMD522. 52) DYNJ908820: UDI/DI 10195327185671 (each), 40195327185672 (case), Lot Numbers: 23JMG465, 23KMI460. 53) DYNJ908820A: UDI/DI 10195327546045 (each), 40195327546046 (case), Lot Numbers: 23LMH559, 24CMA145, 24DMF994, 24DMI666.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medline Industries, LP
Reason for Recall:
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF DYNJ37284K; 12) ACH CABG ADD-ON, REF DYNJ38175L; 13) CARDIOVASCULAR PACK, REF DYNJ42921G; 14) CABG PACK-LF, REF DYNJ43207K; 15) HEART DRAPING PACK-LF, REF DYNJ43214F; 16) AAA PACK, REF DYNJ44847I; 17) CASTRO CABG-COMPONENT PACK, REF DYNJ44857U; 18) FISTULA PACK, REF DYNJ44869K; 19) MAJOR VASCULAR LEG-TEAM, REF DYNJ44879K; 20) PERMANENT PACING, REF DYNJ44886M; 21) CAROTID VASCULAR ENDARTERECTMY, REF DYNJ50528M; 22) DR DANIELSON AC PACK, REF DYNJ51038R; 23) VASCULAR CAROTID PACK, REF DYNJ56838F; 24) VASCULAR FEM PACK, REF DYNJ56839D; 25) PK CUST OPEN HEART A AND B, REF DYNJ60548B; 26) PK CUST CAROTID ST MICHAE, REF DYNJ60783B; 27) CAROTID PACK, REF DYNJ61659A; 28) VASCULAR MINOR PACK, REF DYNJ62097C; 29) VASCULAR PACK-LF, REF DYNJ65039C; 30) PACEMAKER PACK, REF DYNJ66033B; 31) DR MELLINGER AC PACK, REF DYNJ80609D; 32) HEART PACK II, REF DYNJ81581B; 33) AV FISTULA PACK, REF DYNJ81605; 34) MAJOR VASCULAR PACK, REF DYNJ81610B; 35) CABG ACCESSORY PACK, REF DYNJ82166; 36) VALVE ACCESSORY PACK, REF DYNJ82217; 37) PERIVASCULAR CUSTOM PACK, REF DYNJ84017B; 38) CAROTID ENDARTERECTOMY PACK-LF, REF DYNJ85109; 39) ACH OPEN HEART A&B PK, REF DYNJ85110; 40) VASCULAR ABDOMINAL PACK, REF DYNJ85118; 41) AV FISTULA PACK-LF, REF DYNJ85121; 42) CARDIAC - DEEIK PACK, REF DYNJ85637; 43) VASCULAR, REF DYNJ900293K; 44) VASCULAR-LF, REF DYNJ900714C; 45) HEART/MAJOR VASCULAR, REF DYNJ901066K; 46) MODULE OPEN HEART, REF DYNJ903042P; 47) VASCULAR/OR ANGIO, REF DYNJ905079F; 48) OPEN HEART, REF DYNJ905497B; 49) AAA, REF DYNJ906175B; 50) VASCULAR ABDOMINAL, REF DYNJ907105D; 51) CV COMPLETE, REF DYNJ907904A; 52) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820; 53) KIT CV NURSE CENTRAL DUPAGE, REF DYNJ908820A.

Product Codes/Lot Numbers:

1) CDS840261AB: UDI/DI 10195327104535 (each), 40195327104536 (case), Lot Numbers: 23FBF165, 23JBM632. 2) CDS983637I: UDI/DI 10195327228125 (each), 40195327228126 (case), Lot Numbers: 23GBU191. 3) CDS983723J: UDI/DI 10195327327828 (each), 40195327327829 (case), Lot Numbers: 23FBA013, 23FBH486, 23GBE805. 4) CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Numbers: 23GBT133, 23HBH924, 23HBL135, 23HBV936. 5) CDS984255K: UDI/DI 10193489288605 (each), 40193489288606 (case), Lot Numbers: 23KBU348, 24ABB883, 24ABS338. 6) DYNJ0161262C: UDI/DI 10195327357283 (each), 40195327357284 (case), Lot Numbers: 23GDB197, 23GDB757. 7) DYNJ0421380P: UDI/DI 10195327084271 (each), 40195327084272 (case), Lot Numbers: 23DMI590, 23FMJ656. 8) DYNJ21877W: UDI/DI 10195327104542 (each), 40195327104543 (case), Lot Numbers: 23FBT682, 23GBF898, 23IBC645, 24ABR316. 9) DYNJ22350L: UDI/DI 10193489445251 (each), 40193489445252 (case), Lot Numbers: 23LBU055, 24BBQ300. 10) DYNJ27432AC: UDI/DI 10195327104511 (each), 40195327104512 (case), Lot Numbers: 23EBU150, 23GBF873, 23HBQ650, 23IBB637. 11) DYNJ37284K: UDI/DI 10195327401030 (each), 40195327401031 (case), Lot Numbers: 23IBP124, 23KBF938, 24ABS487. 12) DYNJ38175L: UDI/DI 10195327227906 (each), 40195327227907 (case), Lot Numbers: 23FLA915, 23ILA168. 13) DYNJ42921G: UDI/DI 10193489981384 (each), 40193489981385 (case), Lot Numbers: 23FBU282, 23IBT172. 14) DYNJ43207K: UDI/DI 10193489952926 (each), 40193489952927 (case), Lot Numbers: 23EME962. 15) DYNJ43214F: UDI/DI 10193489953077 (each), 40193489953078 (case), Lot Numbers: 23EMA158. 16) DYNJ44847I: UDI/DI 10195327127558 (each), 40195327127559 (case), Lot Numbers: 23HLA758, 23HLB101, 23LLA759. 17) DYNJ44857U: UDI/DI 10195327298067 (each), 40195327298068 (case), Lot Numbers: 23GBI967, 23GBQ950. 18) DYNJ44869K: UDI/DI 10195327127657 (each), 40195327127658 (case), Lot Numbers: 23GBI967, 23GBQ950, 23KMC104. 19) DYNJ44879K: UDI/DI 10195327282233 (each), 40195327282234 (case), Lot Numbers: 23DBI854, 23EBH319, 23GBT541. 20) DYNJ44886M: UDI/DI 10195327127749 (each), 40195327127740 (case), Lot Numbers: 23DBN895, 23EBU129, 23FBQ134, 23GBQ953, 23HBT951. 21) DYNJ50528M: UDI/DI 10195327129699 (each), 40195327129690 (case), Lot Numbers: 23EBA780, 23EBS770, 23GBT274. 22) DYNJ51038R: UDI/DI 10195327298258 (each), 40195327298259 (case), Lot Numbers: 23HBD834. 23) DYNJ56838F: UDI/DI 10195327277857 (each), 40195327277858 (case), Lot Numbers: 23GDA228, 23HDA839. 24) DYNJ56839D: UDI/DI 10195327277864 (each), 40195327277865 (case), Lot Numbers: 23GDA320. 25) DYNJ60548B: UDI/DI 10195327361761 (each), 40195327361762 (case), Lot Numbers: 23EBD777, 23IBS545, 23JBJ740. 26) DYNJ60783B: UDI/DI 10195327361846 (each), 40195327361847 (case), Lot Numbers : 23EBR616, 23GBW384, 23IBV398. 27) DYNJ61659A: UDI/DI 10193489929638 (each), 40193489929639 (case), Lot Numbers: 23HBI627. 28) DYNJ62097C: UDI/DI 10195327189839 (each), 40195327189830 (case), Lot Numbers: 23DBJ117, 23EBD473, 23HBQ663, 23IBB641. 29) DYNJ65039C: UDI/DI 10195327528256 (each), 40195327528257 (case), Lot Numbers: 24BMF955, 24CMB409, 24CME382, 24FMH176. 30) DYNJ66033B: UDI/DI 10195327680589 (each), 40195327680580 (case), Lot Numbers: 24EBA176. 31) DYNJ80609D: UDI/DI 10195327298296 (each), 40195327298297 (case), Lot Numbers: 23HBR318, 23HBZ183. 32) DYNJ81581B: UDI/DI 10195327379254 (each), 40195327379255 (case), Lot Numbers: 23EBO537, 23GBQ499, 23HBG425. 33) DYNJ81605: UDI/DI 10195327123888 (each), 40195327123889 (case), Lot Numbers: 23DBL829, 23EBI374, 23EBM656. 34) DYNJ81610B: UDI/DI 10195327398316 (each), 40195327398317 (case), Lot Numbers: 23EBA748, 23IBP506. 35) DYNJ82166: UDI/DI 10195327182564 (each), 40195327182565 (case), Lot Numbers: 23FDA955. 36) DYNJ82217: UDI/DI 10195327183585 (each), 40195327183586 (case), Lot Numbers: 23DDB931, 23HDA667. 37) DYNJ84017B: UDI/DI 10198459253089 (each), 40198459253080 (case), Lot Numbers: 25CMF132. 38) DYNJ85109: UDI/DI 10195327460594 (each), 40195327460595 (case), Lot Numbers: 23JBD986. 39) DYNJ85110: UDI/DI 10195327460792 (each), 40195327460793 (case), Lot Numbers: 23KBF140. 40) DYNJ85118: UDI/DI 10195327460730 (each), 40195327460731 (case), Lot Numbers: 23KBI277. 41) DYNJ85121: UDI/DI 10195327460853 (each), 40195327460854 (case), Lot Numbers: 23IBR236, 23JBC564. 42) DYNJ85637: UDI/DI 10195327528188 (each), 40195327528189 (case), Lot Numbers: 24CBL150. 43) DYNJ900293K: UDI/DI 10195327554064 (each), 40195327554065 (case), Lot Numbers: 24ABE610, 24BBT270, 24DBU219. 44) DYNJ900714C: UDI/DI 10193489951363 (each), 40193489951364 (case), Lot Numbers: 23FBL767, 23HBW562, 23JBF697. 45) DYNJ901066K: UDI/DI 10195327239282 (each), 40195327239283 (case), Lot Numbers: 23HBB464, 23HBC020, 23JBF553, 23JBW634. 46) DYNJ903042P: UDI/DI 10195327438388 (each), 40195327438389 (case), Lot Numbers: 23JBL424, 23LBL094, 24ABS138. 47) DYNJ905079F: UDI/DI 10195327209001 (each), 40195327209002 (case), Lot Numbers: 23GBV464, 23HBO354. 48) DYNJ905497B: UDI/DI 10193489951639 (each), 40193489951630 (case), Lot Numbers: 23GBB505, 23HBN192, 23JBV542, 23JBV684. 49) DYNJ906175B: UDI/DI 10195327480127 (each), 40195327480128 (case), Lot Numbers: 24FMI570. 50) DYNJ907105D: UDI/DI 10195327233624 (each), 40195327233625 (case), Lot Numbers: 23EBG144, 23EBT013, 23FBI805, 23FBQ992. 51) DYNJ907904A: UDI/DI 10193489992434 (each), 40193489992435 (case), Lot Numbers: 23JME513, 23KMD522. 52) DYNJ908820: UDI/DI 10195327185671 (each), 40195327185672 (case), Lot Numbers: 23JMG465, 23KMI460. 53) DYNJ908820A: UDI/DI 10195327546045 (each), 40195327546046 (case), Lot Numbers: 23LMH559, 24CMA145, 24DMF994, 24DMI666.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0513-2026

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