Agency classClass IOur severity:Severe FDA (Devices)·Z-1113-2021·Announced 2021-02-24

Combat Medical Systems Recalls Fresh Whole Blood Transfusion Sets

Combat Medical Systems is recalling Fresh Whole Blood Transfusion Sets due to a potential for bent or disconnected needles in the kit components.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is the potential of a bent or disconnected needle in one of the components of the convenience kits."

Plain-English summary

Combat Medical Systems, LLC is recalling 27,090 units of Fresh Whole Blood Transfusion Sets (P/N 80-801 NSN 6515016574750). These blood convenience kits contain components necessary to test for ABO/Rh compatibility and perform fresh whole blood transfusions.

The recall was initiated because there is a potential for a bent or disconnected needle in one of the components of the convenience kits. The affected products were distributed nationwide in the United States.

Consumers should stop using the affected products and contact the manufacturer for further instructions. The recall covers specific lot numbers, including MFG2980, MFG3051, and MFG3059, among others.

The recalled product

Product: Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
Manufacturer: Combat Medical Systems, LLC
Category: Medical Device — Blood Transfusion Equipment
Hazard: needle-injury
Affected units: 27,090

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot numbers: MFG2980
MFG3051
MFG3059
MFG3069
MFG3070
MFG3096
MFG3101
MFG3107
MFG3127
MFG3138
MFG3164
MFG3174
MFG3193
MFG3203
MFG3217
MFG3228
MFG3234
MFG3239
MFG3258
MFG3264

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Combat Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Combat Medical Systems, LLC

See all →

Severe
Combat Medical Systems Recalls Valkyrie LTOWB Blood Collection Kits
FDA (Devices) · 2021-02-24
Critical
Combat Medical Systems Recalls Fresh Whole Blood Donor Sets
FDA (Devices) · 2021-02-24
Severe
Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets
FDA (Devices) · 2021-02-24
Severe
Combat Medical Systems Recalls Valkyrie LTOWB Blood Administration Kits
FDA (Devices) · 2021-02-24

Same hazard · needle injury