27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for th

FDA device recall Z-1728-2013 · posted 2013-07-13 · Terminated

Recall details

Recalling firm

Karl Storz Endoscopy America Inc

Reason for recall

Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.

Action taken

The firm, Karl Storz, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated May 31, 2013 to all customers who purchased the 27023WU Balloon Catheter. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and to return the recalled product back to Karl Storz.. The customers were also instructed to complete and fax back the Recall Response Form attached with the safety alert letter at Fax #424-218-8559. If you have any questions, please feel free to call 424-218-8289.

Root cause

Packaging

Status

Terminated

Product code

GBA

Quantity affected

40 units

Distribution

US distribution to: AZ, FL, IL, IN and TX.

Date initiated

2013-05-31

Date posted

2013-07-13

Date terminated

2013-07-15

Location

Southbridge, MA