Z-0152-2016Class II

PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub...

Name: Z-0152-2016 PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub...
Creator: Smiths Medical ASD, Inc.
Published: 2015-09-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-09-14 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of 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... on 2015-09-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0152-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-10-21
Terminated: 2016-05-09
Recalling firm: Abbott Medical
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.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
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.
Root cause tag: labeling and UDI
FDA 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: [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.
Quantity in commerce: 130 Cartons (1560 needles)
Distribution: Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
Product codes and lots: Lot 46262

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0152-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0152-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-21

Product code LJT

K830730Class IIPort-a-Cath Implantable Cath. SysPharmacia, Inc. / cleared 1983-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)