Z-1595-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 23, 2025
- Initiation Date
- March 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 573 units
Product Description
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PACK SMGH, Model Number: DYNJ41929D; 5) DENTAL PACK, Model Number: DYNJ51841C; 6) NYGH-MINOR DENTAL-PLASTIC-LF, Model Number: DYNJ905551C
Reason for Recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Code Information
1) DYNJ84880, UDI-DI: 10195327432140(each), 40195327432141(case), Lot Number: 24JBL926; 2) DYNJ56229A, UDI-DI: 10198459108105(each), 40198459108106(case), Lot Number: 24JBV124; 3) PHS807626F, UDI-DI: 10198459028045(each), 40198459028046(case), Lot Number: 24JBV611; 4) DYNJ41929D, UDI-DI: 10198459160585(each), 40198459160586(case), Lot Number: 24JBW877; 5) DYNJ51841C, UDI-DI: 10195327522186(each), 40195327522187(case), Lot Number: 24KBA623; 6) DYNJ905551C, UDI-DI: 10195327556099(each), 40195327556090(case), Lot Number: 24KBN091