Agency classClass IIOur severity:High FDA (Devices)·Z-0946-2023·Announced 2023-01-18

Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss

Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.

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: This is a Class II medical device recall involving sterile injection equipment with a potential for loss of sterility. While no illnesses or injuries have been reported to date, non-sterile syringes represent a clear risk of serious infection if used for injections, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Stradis Healthcare is recalling Tacy Medical Syringe Convenience Packs (sterile, 60 packs per bag, 5 bags per case) due to potential pinhole leaks near the seal that may result in a breach in the sterility of the kit. A total of 275 units were distributed across Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.

Non-sterile syringes used for injections pose a risk of infection. The affected lots are 222270319 and 220834335, identifiable by Assembly Number TM.SCP1ML and UDI-DI M752TMSCP1ML0.

Healthcare providers and patients who have received or used affected syringe convenience packs should contact their healthcare provider to determine if they have received an affected product and discuss appropriate next steps.

The recalled product

Product: Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Manufacturer: Stradis Healthcare
Category: Medical Device — Sterile Injectable Supplies
Hazard: sterility-breach
infection-risk
Affected units: 275

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)

Assembly Number TM.SCP1ML
UDI-DI: M752TMSCP1ML0
Lot Numbers: 222270319
220834335

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 18 recalled by Stradis Healthcare 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 18 products in this recall →

Same manufacturer · Stradis Healthcare

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