Hospira Inc.: LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures

Recall number

Z-1624-2014

Recalling firm

Hospira Inc.

Product

LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures

Status

Terminated

Initiated

2014-03-25

Posted

2014-05-16

Terminated

2016-12-06

Reason

The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea

Root cause

Process design

Action

Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated March 25, 2014 to all affected customers. The letter included instructions for the direct accounts to: 1) check their inventories and quarantine any of the affected products; 2) complete and return the attached reply form to the fax number or e-mail address on the form; 3) inform potential users of these products of this recall; 4) return the affected products to Stericycle using the labels provided with the letter (additional labels or reply forms can be obtained by calling Stericycle at 877-377-5128, Monday - Friday, 8:00 AM - 5:00 PM EST); and, 5) if the products were further distributed, notify those customers and request that they contact Stericycle at 877-377-5128 (Monday - Friday, 8:00 AM - 5:00 PM EST). An updated URGENT MEDICAL DEVICE RECALL letter dated March 28, 2014 was sent to all affected customers. The letter contained instructions similar to those found in the March 25, 2014 letter.

Quantity

1,109,321 set (US); 15,113 sets (Foreign)

Distribution

Worldwide Distribution - US: Nationwide in the states of (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, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates

Lot, serial or model codes

List No. 6543-04-01 (6543-01); Lot Numbers: 13106NS, 13170NS, 13251NS, 14261NS, 14262NS, 15139NS, 16117NS, 17131NS, 17132NS, 17184NS, 18110NS, 18111NS, 18182NS, 19133NS, 20122NS, 20123NS, 20124NS, 20205NS, 22146NS, 22147NS, 22148NS, 22149NS, 23103NS, 23104NS, 23105NS, 23106NS, 24156NS, 25130NS, 25131NS, 27109NS, 27253NS, 27286NS, 28136NS, 28137NS, 29094NS, 29095NS, 29096NS, 30194NS, 30195NS, 30196NS, 31042NS, 31043NS, 32229NS, 32230NS, 33138NS, 33139NS, 33140NS, 34286NS, 35117NS

510(k) numbers

not on file

PMA numbers

not on file

Product code

GBX

Firm FEI

3013319212

Firm city

Lake Forest

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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