Z-2251-2017 Class II Terminated
FDA device recall Z-2251-2017 was initiated by Teleflex Medical on May 9, 2017 and is designated Class II. Reason for recall: Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device. The recall status is terminated (terminated January 16, 2025). Affected quantity: 1150 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- May 9, 2017
- Termination Date
- January 16, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1150 units
Product Description
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Reason for Recall
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Distribution Pattern
CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Code Information
Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.