Important Notification:
Red Cell Collection Kits
DATE NOTIFICATION INITIATED:
September 8, 2008
PRODUCT / LOT NUMBER/ EXPIRATION DATE:
Red Cell Collection Kits
Product Code: LN822-00
| Lot Number | Expiration Date |
|---|---|
| E08099 | 5/2011 |
| E08102 | 5/2011 |
| F08158 | 6/2011 |
| F08163 | 6/2011 |
| F08169 | 6/2011 |
| F08175 | 6/2011 |
Product Code: LN832-00
| Lot Number | Expiration Date |
|---|---|
| E08200 | 5/2011 |
| E08208 | 5/2011 |
| F08052 | 6/2011 |
| F08062 | 6/2011 |
| F08071 | 6/2011 |
| F08079 | 6/2011 |
| F08098 | 6/2011 |
| F08108 | 6/2011 |
| F08119 | 6/2011 |
| F08129 | 6/2011 |
| F08133 | 6/2011 |
| F08190 | 6/2011 |
| F08193 | 6/2011 |
| F08201 | 6/2011 |
| F08208 | 6/2011 |
| F08211 | 6/2011 |
| G08096 | 7/2011 |
| G08104 | 7/2011 |
| G08114 | 7/2011 |
MANUFACTURER:
Haemonetics Corporation
Braintree, Massachusetts
REASON:
Haemonetics Corporation has identified an issue on their LN 822 and LN 832 red cell kits. The issue relates to the printed numbers found on the segmented sample tubing attached to the product bags on the kits. The numbering sequence may include nine consecutive numbers that match and one that does not. The discrepant number could be located at the distal end of the tubing or located closest to the product bag. Customers who wish to return any kits with discrepant numbers should contact Haemonetics.
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.