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

FDA device recall Z-0152-2016 · posted 2015-10-21 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

LJT

Quantity affected

130 Cartons (1560 needles)

Distribution

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

Date initiated

2015-09-14

Date posted

2015-10-21

Date terminated

2016-05-09

Location

Saint Paul, MN

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