Urgent Medical Device Recall For Acrodose PLus and PL Systems
DATE RECALL INITIATED:
March 28, 2018
PRODUCT / LOT NUMBER:
Acrodose PLus and PL Systems (codes 732-82, 732-83, & 732-86)
This recall applies ONLY to products listed below.
| Product Code | Affected Lot # | Product Description |
|---|---|---|
| 732-82 | 1754045 | PLATLT STR ACRODSE PL ATV EBDS |
| 732-82 | 1754067 | PLATLT STR ACRODSE PL ATV EBDS |
| 732-82 | 1754068 | PLATLT STR ACRODSE PL ATV EBDS |
| 732-82 | 1754070 | PLATLT STR ACRODSE PL ATV EBDS |
| 732-82 | 1754084 | PLATLT STR ACRODSE PL ATV EBDS |
| 732-82 | 1854001 | PLATLT STR ACRODSE PL ATV EBDS |
| 732-82 | 1754085 | PLATLT STR ACRODSE PL ATV EBDS |
| Product Code | Affected Lot # | Product Description |
|---|---|---|
| 732-83 | 1754089 | PLATELET STOR ACRODOSE PL ATV |
| 732-86 | 1754048 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754054 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754069 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754071 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754072 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754074 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754075 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754086 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754087 | PLATELET STOR BAG 5-DAY POOL |
| 732-86 | 1754090 | PLATELET STOR BAG 5-DAY POOL |
MANUFACTURER:
Haemonetics Corporation
Braintree, MA
REASON:
Haemonetics has recently received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose PLus and PL systems (see details below). In some instances the drop in pH is accompanied by a yellow discoloration of the storage bag.
Platelets with pH lower than 6.2 and a lack of “swirl” may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion, increasing risk of morbidity and mortality.
Haemonetics is asking customers who received product affected by this recall to please discontinue use.
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.