The Recall Desk
SevereFDA (Devices)·Z-1073-2018·Announced 2018-03-21

Smiths Medical Recalls Misassembled Port-A-Cath Implantable Port Kits

Smiths Medical ASD Inc. is recalling certain Port-A-Cath II kits that may contain incorrect introducer sizes or locking collars due to misassembly.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant injury from using an incorrectly sized medical device.

Plain-English summary

Smiths Medical ASD Inc. is recalling specific models and lots of PORT-A-CATH II PS/Titan implantable port kits. The recall involves 1,077 units distributed worldwide, including the United States (nationwide including Puerto Rico), Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.

The affected kits may have been misassembled, potentially containing a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. Additionally, the Power PORT-A-CATH II kit may contain incorrect locking collars in addition to the incorrect sized introducer. The specific affected items include Item No. 21-4071-24 (Lot No. 86X046, 87X050), Item No. 21-8066-24 (Lot No. 87X178), and Item No. 21-8068-24 (Lot No. 87X179).

This is an FDA Class II recall. Healthcare providers and patients should contact Smiths Medical ASD Inc. for further instructions regarding the replacement or return of these devices.

The recalled product

Product
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Implantable Port
Hazard
Affected units
1,077

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • a. Item No. 21-4071-24 (Lot No. 86X046
  • 87X050)
  • b. Item No. 21-8066-24 (Lot No. 87X178)
  • c. Item No. 21-8068-24 (Lot No. 87X179)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · misassembly

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