Z-2985-2024Class II
Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack... 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-2985-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK
- Product code
- OFR Tracheobronchial Suction Catheter 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
- DYNJ59573A , Lot Number 23IBP764 ; DYNJ59573A , Lot Number 23JBM050 ; DYNJ59573A , Lot Number 23KBM610 ; DYNJ59573A , Lot Number 24ABC779 ; DYNJ39451D , Lot Number 22BDB647 ; DYNJ39451D , Lot Number 22CDA099 ; DYNJ39451D , Lot Number 22LDA195 ; DYNJ39451D , Lot Number 23DDB501 ; DYNJ39451D , Lot Number 23DDB666 ; DYNJ39451D , Lot Number 23EDA821 ; DYNJ80281A , Lot Number 23ADA194 ; DYNJ80281A , Lot Number 23DDA881 ; DYNJ80281A , Lot Number 23HDA513 ; DYNJ80281A , Lot Number 23JDC172 ; DYNJ80281A , Lot Number 23LDB860 ; DYNJ80281A , Lot Number 24ADC258 ; DYNJ80281A , Lot Number 24CDA973
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.