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DATE RECALL INITIATED:
PRODUCT / LOT NUMBER:
Baxter ALYX Red Kit Disposables (Designed for the ALYX Component Collection System)
| 4R5701 |
All lot numbers starting with H04J, H04K, H04L, H05A, H05B, H05C, H05D, H05E, H05F, H05G, and H05H (except those suffixed with “A”) |
| 4R5701 |
H05I02028 (but NOT H05I02028A) |
| 4R5701 |
H05I13041 (but NOT H05I13041A) |
| 4R5701 |
H05I19071 (but NOT H05I19071A) |
Unaffected lots include any lot numbers labeled with an “A” suffix.
MANUFACTURER:
Baxter Healthcare Corporation
Round Lake, Illinois
REASON:
Baxter Healthcare Corporation has received reports from users of the ALYX Component Collection System of leaks from the cassette of the disposable kit. Such leaks have a potential to create a breach of the sterile pathway within the cassette with a theoretical risk of bacteremia to donors if there has been blood returned to the donor before the leak was detected. To date Baxter has received no complaints of bacteremia associated with this issue. Consignees have been asked to contact the manufacturer to arrange for product return.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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