Agency classClass IOur severity:Severe FDA (Devices)·Z-1112-2021·Announced 2021-02-24

Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets

Combat Medical Systems, LLC is recalling 1021 units of Low Titer Type O FWB Transfusion Sets due to the potential for bent or disconnected needles in the 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 classification is FDA Class I, which per the rubric mandates a minimum severity score of 4. The defect involves a bent or disconnected needle in a device used to administer blood, representing a significant risk of injury.

Plain-English summary

Combat Medical Systems, LLC has issued a recall for its Low Titer Type O FWB Transfusion Sets (P/N 80-875, NSN 651501684994). The product is described as a blood convenience kit that includes the items necessary to administer collected blood to a patient. A total of 1,021 units are being recalled.

The recall was initiated because there is the potential for a bent or disconnected needle in one of the components of the convenience kits. This defect could compromise the safety and functionality of the device during use.

Affected products were distributed nationwide across the United States. The specific lot numbers included in this recall are MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, and MFG3640.

The U.S. Food and Drug Administration has classified this recall as a Class I recall, which is the most serious category of recall used by the FDA.

The recalled product

Product: Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
Manufacturer: Combat Medical Systems, LLC
Category: Medical Device — Transfusion Set
Hazard: needle-defect
device-failure
Affected units: 1,021

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 (18)

Lot Numbers: MFG2267
MFG2347
MFG2375
MFG2430
MFG2538
MFG2637
MFG2655
MFG2693
MFG2708
MFG2754
MFG2828
MFG3120
MFG3186
MFG3340
MFG3378
MFG3386
MFG3586
MFG3640

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 Fresh Whole Blood Transfusion Sets
FDA (Devices) · 2021-02-24
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 Valkyrie LTOWB Blood Administration Kits
FDA (Devices) · 2021-02-24

Same hazard · needle defect