Z-1625-2014Class II

LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder...

Name: Z-1625-2014 LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder...
Creator: Hospira Inc.
Published: 2014-03-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-03-25 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container... on 2014-03-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1625-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-25
Posted: 2014-05-16
Terminated: 2016-12-06
Recalling firm: Abbott Medical
Product: LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation
Product code: LJH System, Irrigation, Urological
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 1,613,775 sets
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
Product codes and lots: List No. 6544-04-01 (6544-01); Lot Numbers: 13107NS, 13108NS, 13171NS, 13172NS, 15141NS, 15142NS, 15143NS, 16113NS, 16114NS, 16115NS, 16116NS, 16174NS, 16175NS, 16176NS, 17134NS, 18112NS, 19130NS, 19131NS, 19132NS, 20119NS, 20120NS, 20121NS, 21130NS, 21131NS, 21207NS, 22144NS, 22145NS, 23107NS, 23108NS, 23109NS, 23110NS, 23111NS, 23112NS, 24194NS, 24204NS, 25133NS, 25254NS, 27110NS, 27111NS, 27155NS, 28192NS, 28271NS, 28272NS, 29097NS, 29170NS, 29171NS, 30197NS, 30198NS, 30199NS, 30200NS, 31044NS, 31045NS, 32231NS, 32232NS, 32391NS, 33328NS, 34170NS, 34170NS, 34171NS, 34287NS, 35115NS, 35116NS, 35250NS, 36160NS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1625-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1623-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16
Z-1624-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16
Z-1625-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16
Z-1626-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16
Z-1627-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-16

Product code LJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)