Perifix LOR Syringes Recalled Due to Temperature Exposure During Storage
Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.
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: FDA Class II recall of a medical device with potential to impact product effectiveness due to temperature exposure. No reported illnesses or injuries, and the hazard is theoretical. Per the rubric, recalls with no reported harm and theoretical hazards score at most 3 (High).
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling 415 Perifix LOR Syringes (Model 332152, 8 mL, Luer Lock Tip Without Safety) distributed nationwide.
The syringes were exposed to temperature excursions (higher-than-specified temperatures) between June and August 2021 at a facility prior to delivery. Exposure to these elevated temperatures may have impacted the product's effectiveness.
This recall affects all lots received between June 1, 2021, and September 30, 2021. Healthcare facilities and providers who received these syringes should identify affected inventory and take appropriate action.
No illnesses or injuries have been reported to date. Consumers should contact their supplier or Mckesson Medical-Surgical Inc. for guidance on returning or replacing affected syringes.
The recalled product
- Product
- Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Syringe
- Hazard
- temperature-excursion
- product-degradation
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 (2)
- GTIN: 04046964177613
- 04046964177620
Distribution
Distributed nationwide across the United States.
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