—#139895

Product

PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K830730
Affected lot / code info: Lot 46262

Why it was recalled

The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

The firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 9/14/2015 to customers. The letter described the product, problem, and actions to be taken. The customers were instructed to Inspect your inventory for and quarantine the affected product, complete and return attached Confirmation form via fax to: 1-651-747-4959 or email to: recall.response@smiths-medical.com within 10 days; upon receipt of completed form, customer representative will contact you and arrange for exchange of your unused affected product; send a copy of letter and confirmation form to your customers identified, replacement product will be arranged for your customers; provide email confirmation of your customer notification to Smiths Medical at recall.response@smiths-medical.com, and notify downstream customers who may have received the product. If you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at 1-800-258-5361.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.

Timeline

Recall initiated: 2015-09-14
Posted by FDA: 2015-10-21
Terminated: 2016-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139895. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.