Z-3022-2024Class II
Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Convenience kits labeled as: SCS-LF, DYNJ902314D on . FDA classified it as Class II and gives the reason as "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-3022-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
- Product code
- LRW Scissors, General, Surgical
- Reason for recall
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
- Distribution
- Worldwide distribution.
- Product codes and lots
- DYNJ902314D, Lot Number 20FDA446 ; DYNJ902314D, Lot Number 20GDA480 ; DYNJ902314D, Lot Number 20IDA880 ; DYNJ902314D, Lot Number 20JDA187 ; DYNJ902314D, Lot Number 21CDA064 ; DYNJ902314D, Lot Number 21EDA709 ; DYNJ902314D, Lot Number 21EDA908 ; DYNJ902314D, Lot Number 21FDA451 ; DYNJ902314D, Lot Number 21FDB959 ; DYNJ902314D, Lot Number 21HDA759 ; DYNJ902314D, Lot Number 21IDC401 ; DYNJ902314D, Lot Number 21KDC395 ; DYNJ902314D, Lot Number 22CDA599 ; DYNJ902314D, Lot Number 22EDB585 ; DYNJ902314D, Lot Number 22IDA541 ; DYNJ902314D, Lot Number 22KDB745 ; DYNJ902314D, Lot Number 23BDA383 ; DYNJ902314D, Lot Number 23DDB444 ; DYNJ902314D, Lot Number 23EDA371
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2981-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2982-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2983-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2984-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2985-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2986-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2987-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2988-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2989-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2990-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2991-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2992-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2993-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2994-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2995-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2996-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2997-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2998-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2999-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3000-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3001-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3002-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3003-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3004-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3005-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3006-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3007-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3008-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3009-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3010-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3011-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3012-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3013-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3014-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3015-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3016-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3017-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3018-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3019-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3020-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3021-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3022-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3023-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3024-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3025-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3026-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3027-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3028-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3029-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3030-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3031-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3032-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3033-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3034-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3035-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3036-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3037-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3038-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3039-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3040-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3041-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3042-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3043-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3044-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3045-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3046-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3047-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3048-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3049-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3050-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3051-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3052-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3053-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3054-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3055-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3056-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3057-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3058-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3059-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3060-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-3061-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.