Recall Z-1595-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-03-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-03
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.