Agency classClass IOur severity:Severe FDA (Devices)·Z-1110-2021·Announced 2021-02-24

Combat Medical Systems Recalls Valkyrie LTOWB Blood Collection Kits

Combat Medical Systems is recalling 531 Valkyrie LTOWB blood collection kits due to a potential for bent or disconnected needles.

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 531 units of the Valkyrie LTOWB Collection (P/N 80-820, NSN 651501686242). This product is a blood collection convenience kit designed to allow for pre-screening to identify Low Titer Type O Donors and to collect blood from the donor.

The recall was initiated because there is the potential for a bent or disconnected needle in one of the components of the convenience kits. The affected lot numbers are MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, and MFG3671.

The product was distributed nationwide in the United States. Users should stop using the affected kits and contact Combat Medical Systems for further instructions.

The recalled product

Product: Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.
Manufacturer: Combat Medical Systems, LLC
Category: Medical Device — Blood Collection Kit
Hazard: needle-injury
Affected units: 531

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 (10)

Lot Numbers: MFG3204
MFG3327
MFG3350
MFG3455
MFG3541
MFG3573
MFG3582
MFG3648
MFG3659
MFG3671

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
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