FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: 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.
- Recall number
- Z-0152-2016
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-09-14
- Posted
- 2015-10-21
- Terminated
- 2016-05-09
- Reason
- 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
- Labeling mix-ups
- 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: 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.
- Quantity
- 130 Cartons (1560 needles)
- Distribution
- Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
- Lot, serial or model codes
- Lot 46262
- 510(k) numbers
- ["K830730"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 2183502
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28