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Terminated

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 Recall Z-0152-2016 · Posted 2015-10-21

Recall StatusTerminated
Product CodeLJT
Date Initiated2015-09-14
Date Terminated2016-05-09
Product Quantity130 Cartons (1560 needles)

Reason for Recall

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.

Firm Action

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: [email protected] 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 [email protected], 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.

Root Cause

Labeling mix-ups

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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