Combat Medical Systems Recalls Fresh Whole Blood Donor Sets
Combat Medical Systems is recalling 954 Fresh Whole Blood Donor Sets due to a potential bent or disconnected needle 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Combat Medical Systems, LLC is recalling 954 units of the Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306). This blood convenience kit is designed to test for ABO/Rh compatibility and collect whole blood from donors. The affected units were distributed nationwide in the United States.
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 specific lot numbers affected are MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, and MFG3857.
The U.S. Food and Drug Administration has classified this as a Class I recall. Consumers and medical facilities should stop using these kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
- Manufacturer
- Combat Medical Systems, LLC
- Hazard
- Affected units
- 954
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: MFG2977
- MFG2991
- MFG3073
- MFG3118
- MFG3279
- MFG3328
- MFG3332
- MFG3337
- MFG3339
- MFG3499
- MFG3507
- MFG3512
- MFG3533
- MFG3704
- MFG3751
- MFG3761
- MFG3760
- MFG3857
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 →Related recalls
Same manufacturer · Combat Medical Systems, LLC
See all →- SevereCombat Medical Systems Recalls Fresh Whole Blood Transfusion Sets
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FDA (Devices) · 2019-11-06
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