CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report
Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) recalled
AMD Medicom is recalling Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) (, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1148-2024
- FDA event ID
- 93818
- Recalling firm
- AMD Medicom, Montreal, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +57 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Product as listed by the FDA
PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)
Where it was distributed
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Questions about this recall
Is Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) ( recalled?
Yes. AMD Medicom recalled Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) ( on 21 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-1148-2024.
Why was it recalled?
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Which lots are affected?
Item Code: 127-7573; UDI DI: D6620712775732; Lot #s: 2339, 2342;
Where was it sold?
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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