Agency classClass IOur severity:Severe FDA (Devices)·Z-1111-2021·Announced 2021-02-24

Combat Medical Systems Recalls Valkyrie LTOWB Blood Administration Kits

Combat Medical Systems is recalling 953 Valkyrie LTOWB Administration Sets 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 953 units of the Valkyrie LTOWB Administration Set (P/N 80-821 NSN 6515016862401). This blood convenience kit contains the items needed to administer blood to a patient. The recall was initiated because there is a potential for a bent or disconnected needle in one of the components of the kits.

The affected units were distributed nationwide in the United States. The specific lot numbers involved in this recall are MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, and MFG3698.

Consumers and healthcare providers should stop using these kits and contact Combat Medical Systems, LLC for further instructions or a replacement.

The recalled product

Product: Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.
Manufacturer: Combat Medical Systems, LLC
Category: Medical Device — Blood Administration
Hazard: needle-injury
Affected units: 953

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: MFG3205
MFG3353
MFG3403
MFG3440
MFG3540
MFG3574
MFG3584
MFG3649
MFG3660
MFG3698

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 Low Titer Type O FWB Transfusion Sets
FDA (Devices) · 2021-02-24

Same hazard · needle injury