Recall Z-2593-2016— Hospira Inc.

Class II FDA medical device recall by Hospira Inc., initiated 2013-09-10, terminated 2016-12-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..

Recalling firm

Hospira Inc.

Classification

Class II

Status

Terminated

Initiated

2013-09-10

Terminated

2016-12-15

Firm location

Lake Forest, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.