Product Application Notice: Acrodose PLus Systems
DATE NOTICE INITIATED:
April 5, 2018
PRODUCT / LOT NUMBER:
Affected (Reorder Codes): 732-82 and 732-83
MANUFACTURER:
Haemonetics Corporation
Braintree, MA
REASON:
On March 28, 2018, Haemonetics informed its customers of an urgent recall for specific lots of the Acrodose Plus Systems; reorder codes (732-82 and 732-83) and advised customers to discontinue use of unused affected lots.
Based on customer requests, Haemonetics is advising on a method to utilize an alternate storage bag if local procedures permit.
- Acrodose PL System; reorder code (732-80) is an alternative storage bag, unaffected by the recall and may be utilized by sterile connecting on to the Acrodose PLus System; reorder codes (732-82 and 732-83).
- The sterile connection process should be performed in strict accordance with local blood establishment procedures.
The CLX-HP storage bag on the Acrodose PL System, reorder code (732-80), is interchangeable and functionally equivalent to the CLX-HP storage bag on the Acrodose PLus System, reorder codes (732-82 and 732-83), with the exception of the differences noted below. Follow instructions for pooling and filtration of platelets and storage platelet concentration of <2.0 x 106/ul, as indicated in the Instructions for Use of the original reorder code.
| Product Code | Storage Bag Film | # of Bag ports | Indicated for storage of : |
|---|---|---|---|
| 732-80 | CLX-HP extended storage | 4 | 2.2 – 5.8 X 1011 platelets 3 – 6 platelet concentrates < 2.3 x 106/ µl 180 –420 mL |
| 732-82, 732-83 | CLX-HP extended storage | 3 | 2.2 – 5.8 X 1011 platelets 3 – 6 platelet concentrates < 2.0 x 106/ µl 180 –420 mL |
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.