Recall Z-2594-2016 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Hospira Inc.
Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 4304
| Date | Sep 10, 2013 |
| Status | Terminated |
| Reason | Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. |
| Root cause | Process control |
| Action | URGENT MEDICAL DEVICE RECALL letters dated September 10, 2013 were distributed to direct accounts notifying them of the recall. The letter requests that customers to ensure that they only use liners and canisters of corresponding sizes (e.g. a 1000mL liner with a 1000mL canister) and to only use Hospira components. The letter further advises customers of an ongoing recall of the 1000mL Receptal systems. Customers were requested to complete and return the attached reply form and to notify other healthcare providers within their organization.Customers who further distributed the Receptal systems |
| Quantity | 67,410,861 liners and 67,410,861 lids/canisters in total |
| Distribution | *** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.