Recall Z-1682-2013— Baxter Healthcare Corp.

Name: FDA recall Z-1682-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-15

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-05-15, terminated 2015-06-16. It names one FDA 510(k) clearance: K960787. Product: Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.. Reason: A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Terminated: 2015-06-16
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K960787 — TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSBaxter Healthcare Corp·cleared 1996-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.

Reason for recall

A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.

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