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  1. Safety & Availability (Biologics)

Product Application Notice: Acrodose PLus Systems

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.