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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Labeling Discrepancy- Haemonetics' Plasma Bottle with Saline Adapter

DATE NOTIFICATION INITIATED:

March 2, 2012
 
PRODUCT / LOT NUMBER:
 
0694S-00-Plasma Bottle with Saline Adapter
Lot 1201553B
 
MANUFACTURER:
 
Haemonetics Corporation
Braintree, MA
 
REASON:
 
Haemonetics recently discovered a label discrepancy on the outer carton of Haemonetics’ Plasma Bottles with Saline Adapter lot 1201553B. An undetermined quantity of product from lot number 1201553B contains an incorrect expiration date on the outer carton label only. The individual bottles contained within these cases are labeled correctly with list number, lot number and expiration date. The wrong expiration date is identified by 2014-10, correct expiration date should be 2014-01. Haemonetics has confirmed that this issue is isolated to this specific lot. Customers are asked to contact Haemonetics to arrange for product return.
 
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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.