CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954.

FDA device recall Z-2558-2014 · posted 2014-08-28 · Terminated

Recall details

Recalling firm

Civco Medical Instruments Inc

Reason for recall

A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

Action taken

Civco Medical Instrucments contacted customers by phone and sent an Urgent Medical Device Recall letter dated August 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return all the affected product. Customers were instructed to contact Customer Service at 319-248-6520 with any concerns or questions.

Root cause

Packaging

Status

Terminated

Product code

KQT

Quantity affected

52 kits

Distribution

Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.

Date initiated

2014-08-01

Date posted

2014-08-28

Date terminated

2015-01-28

Location

Kalona, IA