The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0190-2020·Announced 2019-10-30

Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

Smiths Medical ASD Inc. is recalling GRIPPER Needles from the PORT-A-CATH II system because they may be occluded or blocked.

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 3/5 (High).

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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (occluded needle) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Smiths Medical ASD Inc. is recalling GRIPPER Needles sold as part of the PORT-A-CATH II Single Lumen System. The recall involves 3,952,509 devices distributed nationwide and internationally. The specific hazard is the potential for these needles to contain an occluded or blocked needle.

The affected products are identified by specific item numbers and lot numbers, including Item Number 21-4025-24 and Item Number 21-4037-24, among others. The distribution pattern includes all 50 US states, the District of Columbia, Puerto Rico, and international markets.

Healthcare providers and consumers should check their inventory for the specific item numbers and lot numbers listed in the recall notice. If the devices are found, they should be removed from use and returned to Smiths Medical ASD Inc. according to the company's instructions.

The recalled product

Product
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM…
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Needles
Hazard
Affected units
3,952,509

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 (20)

  • 1. Item Number 21-4025-24
  • Lot Numbers 3674105
  • 3694006
  • 3712500
  • 3736641
  • 3748406
  • 3756975
  • 2. Item Number 21-4037-24
  • Lot Numbers 3659767
  • 3674101
  • 3690401
  • 3694005
  • 3703706
  • 3709205
  • 3731036
  • 3765362
  • 3. Item Number 21-4051-24
  • Lot Number: 3624979
  • 4. Item Number 21-4053-24
  • Lot Number 3659766

Distribution

Distributed nationwide across the United States.

The notice also names 52 states 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 · occluded needle

See all →

Similar recalls