Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

Oct 4, 2019 Other Medical Devices Nationwide View Details →

Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47249318211 47249318213 47249318214 47249318309 47249318310 47249318311 47249318313 47249318314 47249321010 47249321011 47249321013 47249321014 47249321110 47249321111 47249321113 47249321114 47249321210 47249321211 47249321213 47249321214 47249321310 47249321311 47249321313 47249321314 47249321410 47249321411 47249321413 47249321414 47249321510 47249321511 47249321513 47249321514 47249330010 47249330011 47249330013 47249330110 47249330111 47249330113 47249330210 47249330211 47249330213 47249330310 47249330311 47249330313 47249330410 47249330411 47249330413 47249330510 47249330511 47249330513 47249332010 47249332011 47249332013 47249332110 47249332111 47249332113 47249332210 47249332211 47249332213 47249332310 47249332311 47249332313 47249332410 47249332411 47249332413 47249332510 47249332511 47249332513 47249334010 47249334011 47249334013 47249334110 47249334111 47249334113 47249334210 47249334211 47249334213 47249334310 47249334311 47249334313 47249334410 47249334411 47249334413 47249334510 47249334511 47249334513 47249336010 47249336011 47249336013 47249336110 47249336111 47249336113 47249336210 47249336211 47249336213 47249336310 47249336311 47249336313 47249336410 47249336411 47249336413 47249336510 47249336511 47249336513 47249338010 47249338011 47249338013 47249338110 47249338111 47249338113 47249338210 47249338211 47249338213 47249338310 47249338311 47249338313 47249338410 47249338411 47249338413 47249338510 47249338511 47249338513 47249340010 47249340011 47249340013 47249340110 47249340111 47249340113 47249340210 47249340211 47249340213 47249340310 47249340311 47249340313 47249340410 47249340411 47249340413 47249340510 47249340511 47249340513 47249342010 47249342011 47249342013 47249342110 47249342111 47249342113 47249342210 47249342211 47249342213 47249342310 47249342311 47249342313 47249342410 47249342411 47249342413 47249342510 47249342511 47249342513 47249344010 47249344011 47249344013 47249344110 47249344111 47249344113 47249344210 47249344211 47249344213 47249344310 47249344311 47249344313 47249344410 47249344411 47249344413 47249344510 47249344511 47249344513 47249346010 47249346011 47249346013 47249346110 47249346111 47249346113 47249346210 47249346211 47249346213 47249346310 47249346311 47249346313 47249346410 47249346411 47249346413 47249346510 47249346511 47249346513 47249348010 47249348011 47249348013 47249348110 47249348111 47249348113 47249348210 47249348211 47249348213 47249348310 47249348311 47249348313 47249348410 47249348411 47249348413 47249348510 47249348511 47249348513

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 00585004608 00585004610 00585004612 00585004614 00585004616 00585004618 00585004620 00585004622 00585004635 00585004645 00585004655 00585004808 00585004809 00585004820 00585204209 00585204217 00585205009 00585205010 00585205011 00585205012 00585205013 00585205014 00585205015 00585205016 00585205017 00585205018 00585205019 00585205209 00585205210 00585205211 00585205212 00585205213 00585205214 00585205215 00585205216 00585205217 00585205218 00585205219 00585205412 00585205413 00585205414 00585205415 00585205416 00585205417 00585205418 00585205419 00585207009 00585207010 00585207011 00585207012 00585207013 00585207014 00585207015 00585207016 00585207017 00585207018 00585207019 00585207409 00585207410 00585207411 00585207412 00585207413 00585207414 00585207415 00585207416 00585207417 00585207418 00585207419 500000001 500000005 500000010 500010000 502000001 502006006 502006011

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

GE Healthcare

Class I - Dangerous

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

Jul 26, 2019 Other Medical Devices Nationwide View Details →

FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Argon Medical Devices

Class I - Dangerous

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Oct 16, 2018 Other Medical Devices Nationwide View Details →

Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Argon Medical Devices

Class I - Dangerous

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Oct 16, 2018 Other Medical Devices Nationwide View Details →

CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202

Zimmer Biomet

Class I - Dangerous

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Oct 10, 2019 Other Medical Devices Nationwide View Details →

Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904

Thermo Fisher Scientific (Monterrey)

Class I - Dangerous

Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial

Jul 18, 2019 Other Medical Devices View Details →

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

Ortho-Clinical Diagnostics

Class I - Dangerous

Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

Sep 10, 2019 Other Medical Devices Nationwide View Details →

Petfine Auto Injector, REF 3310VET

Owen Mumford USA

Class I - Dangerous

There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107

Jul 17, 2019 Other Medical Devices View Details →

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

Helena Laboratories

Class I - Dangerous

Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.

Feb 27, 2018 Other Medical Devices Nationwide View Details →

Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.

Philips Medical Systems (Cleveland)

Class I - Dangerous

An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

Sep 19, 2019 Other Medical Devices Nationwide View Details →

Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.

Philips Medical Systems (Cleveland)

Class I - Dangerous

An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

Sep 19, 2019 Other Medical Devices Nationwide View Details →

Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.

Biomedical Polymers

Class I - Dangerous

The metal cannula of the device either broke and the broken piece left in the blood specimen tube, or slid back into the plastic portion of the device instead of piercing the tube.

Sep 18, 2019 Other Medical Devices Nationwide View Details →

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