Z-0941-2022 Class II Terminated
FDA device recall Z-0941-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Mar 9, 2022 and is designated Class II. Reason for recall: The mask cuff may disconnect from the device's breathing tube. The recall status is terminated (terminated May 26, 2026). Affected quantity: 8990 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Mar 9, 2022
- Termination Date
- May 26, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8990 cases
Product Description
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Reason for Recall
The mask cuff may disconnect from the device's breathing tube.
Distribution Pattern
US Nationwide distribution.
Code Information
Medline Item Number and Lot(s): 1) DYND290010; Lot 63521050001 (UDI: 10193489036688) 2) DYND290015; Lot 63521050001 (UDI: 10193489036695) 3) DYND290020; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036701) 4) DYND290025; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036718) 5) DYND290030; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036725) 6) DYND290040; Lots 63521050001, 63521100002, 63521050002, and 63521110001 (UDI: 10193489036732) 7) DYND290050; Lots 63521050001, 63521110001, and 63521100002 (UDI: 10193489036749)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0941-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026