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PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4… recallZ-0152-2016 · Smiths Medical ASD, Inc. · initiated Sep 14, 2015

Class II Terminated All recalls posted in October 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0152-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 14, 2015
Posted by the FDA
Oct 21, 2015
Recalling firm
Smiths Medical ASD, Inc.
Quantity
130 Cartons (1560 needles)
Product code
LJT
FDA submissions
K830730
Distribution
Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.

Product description

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.

Code information (models, lots, serial numbers)

Lot 46262

Other devices under the same FDA submission

9 devices cleared under K830730 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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