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U.S. Department of Health and Human Services

Class 2 Device Recall Receptal Liners

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  Class 2 Device Recall Receptal Liners see related information
Date Initiated by Firm September 10, 2013
Create Date August 18, 2016
Recall Status1 Terminated 3 on December 15, 2016
Recall Number Z-2594-2016
Recall Event ID 66448
Product Classification Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
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
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 
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact
224-212-2000
Manufacturer 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.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 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, Singapore, South Africa
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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