Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: misassembly
incorrect-size
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 →

Same manufacturer · Smiths Medical ASD Inc.

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