HPS Pharmacies wish to give notice that Fresenius Kabi, in consultation with the Therapeutic Goods Administration (TGA), has given notice of a drug recall for Sodium Chloride 0.9% 500mL and 1000mL freeflex® bags as follows:
Sodium Chloride 0.9% 500mL
Sodium Chloride 0.9% 1000mL
Multiple batches are affected by this recall as follows (please note that ‘xxxxxx’ represents a six-digit number).
- 500mL bags: 82MCxxxxxx, 82MDxxxxxx, 82MFxxxxxx, 82MGxxxxxx, 82MHxxxxxx, 82MKxxxxxx, 82MLxxxxxx, 82MMxxxxxx, 82NAxxxxxx, 82NBxxxxxx, 82NCxxxxxx, 82NDxxxxxx, 82NGxxxxxx, 82NHxxxxxx, 82NIxxxxxx 82NKxxxxxx, 82NLxxxxxx, 82NMxxxxxx, 82PBxxxxxx, and 82PDxxxxxx.
- 1000mL bags: 82MExxxxxx, 82MGxxxxxx, 82MIxxxxxx,82MLxxxxxx, 82NDxxxxxx 82NExxxxxx, 82NIxxxxxx, 82NKxxxxxx,82NMxxxxxx, 82PAxxxxxx, 82PCxxxxxx, and 82PDxxxxxx
These batches are being recalled following reports of these bags bursting when used in a pressure cuff for a prolonged period of time. The root cause analysis found that the issue was caused by temperature deviations during the bag welding process at one of the production units. Replacement stock will be issued from unaffected production units.
Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.
Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.
Should you require further information regarding this matter, please contact Fresenius Kabi on 1300 361 004 or your pharmacist at HPS Pharmacies.