Z-2593-2016 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-2593-2016 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 CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE 2) List Numbers 43423-01 and 43423-21; LIST NO. 43423; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; 1400. 3) List Numbers 43445-01 and 43445-11; LIST NO. 43445; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; DO NOT FILL 1900 ABOVE THIS LINE. 4) List Number 43496-01.

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

43423-04-01 43423-04-11 43423-04-21 43445-04-01 43445-04-11 43449-04-01 43449-04-11 43496-04-01

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2593-2016
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.