DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) mi

FDA device recall Z-2595-2014 · posted 2014-09-05 · Terminated

Recall details

Recalling firm

Catheter Connections, Inc.

Reason for recall

Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

Action taken

The firm, Catheter Connections, sent an "Urgent: Medical Device Field Action" letter dated August 5, 2014 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to identify any customers who received this product having lot no. 1406509; make all potential users in your facility are made aware of this notification and the recommended actions; forward the attached URGENT MEDICAL DEVICE CORRECTION LETTER to customers immediately via fax or email; search your inventory and instruct all users to check each cap coming from the specific affected lot; quarantine and discard any defective product; and complete and return the attached URGENT MEDICAL DEVICE FIELD ACTION REPLY FORM via fax to 1-888-862-2693 or email to: info@cathconn.com. Catheter Connections does not require the return of devices having the affected lot number. If you have questions, please contact Catheter Connections at 1-801-906-0820 (M-F, 8:00 am - 5:00 pm MST) and ask for Quality Department.

Root cause

Packaging

Status

Terminated

Product code

LKB

Quantity affected

24,910 units

Distribution

US Distribution to states of: CT, GA, MD, and PA. .

Date initiated

2014-08-05

Date posted

2014-09-05

Date terminated

2014-10-08

Location

Salt Lake City, UT

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