The Recall Desk
HighFDA (Devices)·Z-1074-2018·Announced 2018-03-21

Smiths Medical Recalls Misassembled Power PORT-A-CATH II Implantable Port Kits

Smiths Medical ASD Inc. is recalling 1,077 units of Power PORT-A-CATH II kits that may contain incorrect introducer sizes or locking collars.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential assembly error that could lead to improper use or injury, but the source text does not report any specific illnesses, injuries, or fatalities, placing it in the 'risk-of-harm products where injury has not yet been reported' category.

Plain-English summary

Smiths Medical ASD Inc. is recalling 1,077 units of Power PORT-A-CATH II and Tray Power Pac II implantable port kits. The recall covers specific models and lots distributed worldwide, including the United States, Puerto Rico, and several international locations.

The recall was initiated because certain kits may have been misassembled. Specifically, the kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the required 8.5Fr size introducer. Additionally, the Power PORT-A-CATH II kits may contain incorrect locking collars in addition to the incorrect sized introducer.

Healthcare providers and facilities should check their inventory for the specific item numbers and lot numbers listed in the recall notice. Affected units should be removed from use and returned to the manufacturer or their authorized representative according to the instructions provided by Smiths Medical ASD Inc.

The recalled product

Product
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, 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 (14)

  • a. Item No. 21-4474-24 (Lot No. 87X040
  • 87X117)
  • b. Item No. 21-4475-24 (Lot No. 87X044)
  • c. Item No. 21-4477-24 (Lot No. 87X097)
  • d. Item No. 21-8466-24 (Lot No. 87X171)
  • e. Item No. 21-8468-24 (Lot No. 87X172
  • 87X244
  • 87X180)
  • f. Item No. 21-8469-24 (Lot No. 87X151)
  • g. Item No. 21-8470-24 (Lot No. 87X173
  • 87X254
  • 87X194
  • 87X198
  • 87X237)

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.

See all →

Same hazard · misassembly

See all →