Recall of bag systems, Gambro
2007.12.10
Product group Injections / Infusions / Transfusions / Dialysis
Reference 04274/07
The manufacturer Gambro recalls specific lot numbers for the bag systems used with Cobe Spectra Apheresis System and TRIMA automated blood collection System. The secondary platelet collection bag might be leaking. Therefore, all blood products prepared with the affected systems might potentially be non-sterile. Initially, the recall was restricted to specific products of the affected lots (field safety notice dated 28.11.07). It was extend to all products of the affected lots on 04.12.07 (customer notice only available in German). The Paul-Ehrlich-Institute, Langen, will coordinate the risk management of the filled blood bags.
Recall of bag systems, Gambro , Download_VeroeffentlichtAm_EN