CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model TR34L - Part Number(s) 100-100PSLA; 100-101PSLA Serial Number: 58766 58765 26479 69547 69548 26428 26299 26301 26295 26294 26304 26296 26298 26302 26297 26300 26130 26133 26132 58906 58907 58909 58910 58911 58912 58913 58914 58915 58916 58917 58918 58919 58920 58921 58922 58923 58924 58925 58926 58998 59003 59007 58999 59006 59000 59004 59002 59005 59001 69618 69619 69628 69629 69630 69637 69659 69666 69638 69579 70119 70134 70136 70142 70144 70145 70146 70147 70148 70162 70167 70169 70172 70173 70174 70175 70143 S25610 S25720 S25725 S25729 S69776 S69785 S70157 S70160 S70165 S70176 S70192 S70203 S70206 S70207 S70208 S70209 S70210 S70211 S70129 S70177 S70181 S70205 S70114 S70115 S70117 S70118 S70120 S70121 S70124 S70125 S70126 S70127 S70128 S70130 S70131 S70132 S70138 S70139 S70140 S70163 S70164 S70166 S70182 S70183 S70185 S70187 S70188 S70190 S70191 S70194 S70195 S70196 A12200 A12201 S69760 A100795 A100796 A100797 A100798 A100799 A100800 A100801 A100802 A100803 UDI Code: B101100100PSLA0 100-101 PSLA was retired prior to UDI
  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:
CME America, LLC
Reason for Recall:
Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

Product Codes/Lot Numbers:

Model TR34L - Part Number(s) 100-100PSLA; 100-101PSLA Serial Number: 58766 58765 26479 69547 69548 26428 26299 26301 26295 26294 26304 26296 26298 26302 26297 26300 26130 26133 26132 58906 58907 58909 58910 58911 58912 58913 58914 58915 58916 58917 58918 58919 58920 58921 58922 58923 58924 58925 58926 58998 59003 59007 58999 59006 59000 59004 59002 59005 59001 69618 69619 69628 69629 69630 69637 69659 69666 69638 69579 70119 70134 70136 70142 70144 70145 70146 70147 70148 70162 70167 70169 70172 70173 70174 70175 70143 S25610 S25720 S25725 S25729 S69776 S69785 S70157 S70160 S70165 S70176 S70192 S70203 S70206 S70207 S70208 S70209 S70210 S70211 S70129 S70177 S70181 S70205 S70114 S70115 S70117 S70118 S70120 S70121 S70124 S70125 S70126 S70127 S70128 S70130 S70131 S70132 S70138 S70139 S70140 S70163 S70164 S70166 S70182 S70183 S70185 S70187 S70188 S70190 S70191 S70194 S70195 S70196 A12200 A12201 S69760 A100795 A100796 A100797 A100798 A100799 A100800 A100801 A100802 A100803 UDI Code: B101100100PSLA0 100-101 PSLA was retired prior to UDI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0525-2021

Related Recalls

Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.

Jul 30, 2020 Surgical Instruments Nationwide View Details →

Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.

Jul 30, 2020 Surgical Instruments Nationwide View Details →

Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.

Jul 30, 2020 Surgical Instruments Nationwide View Details →