Z-3040-2024Class II
Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION... 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-3040-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2475; 3) CHEST TUBE INSERTION TRAY , Pack Number DYNDA2941A ; 4) PERICARDIAL DRAIN KIT , Pack Number DYNDA2998; 5) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794; 6) KIT, BEDSIDE THORACENTESIS SFT, Pack Number DYNDH1794H ; 7) CHEST TUBE INSERTION PACK , Pack Number DYNJ04474F ; 8) DRAINAGE FOR GRAPEVINE PACK , Pack Number DYNJ66222B ; 9) DRAINAGE PACK , Pack Number DYNJ67988A ; 10) CHEST/BREAST-LF , Pack Number DYNJ83950; 11) IR DRAIN PACK , Pack Number DYNJ85264; 12) INCISION AND DRAINAGE , Pack Number DYNJ904606C; 13) I&D TRAY, Pack Number MNS15250
- Product code
- PAD Chest Drainage Kit
- 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
- CHT2120, Lot Number 23DLA374 ; CHT2120, Lot Number 23ELA871 ; CHT2120, Lot Number 23FLA655 ; DYNDA2475, Lot Number 22IMA813 ; DYNDA2941A , Lot Number 23BMB940 ; DYNDA2941A , Lot Number 23FMF503 ; DYNDA2998, Lot Number 22KBB005 ; DYNDA2998, Lot Number 23BBD525 ; DYNDH1794, Lot Number 22LBM374 ; DYNDH1794, Lot Number 23EBL615 ; DYNDH1794, Lot Number 23LMF847 ; DYNDH1794H , Lot Number 23LMF847 ; DYNDH1794H , Lot Number 22LBM374 ; DYNDH1794H , Lot Number 23EBL615 ; DYNJ04474F , Lot Number 22JLA750 ; DYNJ04474F , Lot Number 23BLA545 ; DYNJ04474F , Lot Number 23FLA171 ; DYNJ66222B , Lot Number 24ALA413 ; DYNJ66222B , Lot Number 24ALA509 ; DYNJ66222B , Lot Number 24CLA156 ; DYNJ67988A , Lot Number 22JMG867 ; DYNJ67988A , Lot Number 22LMI605 ; DYNJ67988A , Lot Number 23AMJ359 ; DYNJ67988A , Lot Number 23DMG616 ; DYNJ67988A , Lot Number 23EMI610 ; DYNJ67988A , Lot Number 23GMB085 ; DYNJ67988A , Lot Number 23IMH819 ; DYNJ67988A , Lot Number 23KMF739 ; DYNJ83950, Lot Number 23CBG610 ; DYNJ83950, Lot Number 23FBF248 ; DYNJ83950, Lot Number 23LBR075 ; DYNJ85264, Lot Number 23KBE782 ; DYNJ904606C, Lot Number 23HBP402 ; DYNJ904606C, Lot Number 23IBS124 ; DYNJ904606C, Lot Number 23JBN042 ; DYNJ904606C, Lot Number 23KBW145 ; MNS15250 , Lot Number 24AMC318
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.