—#127262

Product

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

FDA product code: GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 were requested to forward the letter to their customers and to request that the contact Stericycle at 1-888-943-5175 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to obtain a reply form.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

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

Timeline

Recall initiated: 2013-09-10
Terminated: 2016-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127262. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.