Z-2594-2016 Class II Terminated
Recalled by Hospira Inc.
— Lake Forest, IL
FDA device recall Z-2594-2016 was initiated by Hospira Inc. on Sep 10, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Dec 15, 2016). Affected quantity: 67,410,861 liners and 67,410,861 lids/canisters in total.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 24, 2016
- Initiation Date
- Sep 10, 2013
- Termination Date
- Dec 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,410,861 liners and 67,410,861 lids/canisters in total
Product Description
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 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15
Reason for Recall
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.
Distribution Pattern
*** 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, Singapore, South Africa
Code Information
43001-04-01 43023-04-01 43024-04-01 43024-04-62 43025-04-01 43025-04-11 43025-04-21 43025-04-25 43027-04-01 43027-04-05 43027-04-11 43027-04-14 43027-04-17 43031-04-02 43032-04-05 43034-04-06 43036-04-04 43037-04-02 43038-04-04 43038-04-05 43041-04-01 43042-04-01 43042-04-11 43043-04-01 43044-04-01 43044-04-05 43044-04-11 43044-04-15 43044-04-51 43046-04-01 43046-04-05 43047-04-01 43056-04-01 43061-04-01 43062-04-01 43063-04-01 43064-04-01 0L212-01 0L213-01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2594-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.