510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-3058-2024Class II

Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
FDA source (opens on fda.gov)

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229 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-3058-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
Product code
MJG Device, Percutaneous, Biopsy
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
DYNDH1229 , Lot Number 22FBA002

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-3058-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2981-2024Class IIOngoingVoluntary: Firm initiated
Z-2982-2024Class IIOngoingVoluntary: Firm initiated
Z-2983-2024Class IIOngoingVoluntary: Firm initiated
Z-2984-2024Class IIOngoingVoluntary: Firm initiated
Z-2985-2024Class IIOngoingVoluntary: Firm initiated
Z-2986-2024Class IIOngoingVoluntary: Firm initiated
Z-2987-2024Class IIOngoingVoluntary: Firm initiated
Z-2988-2024Class IIOngoingVoluntary: Firm initiated
Z-2989-2024Class IIOngoingVoluntary: Firm initiated
Z-2990-2024Class IIOngoingVoluntary: Firm initiated
Z-2991-2024Class IIOngoingVoluntary: Firm initiated
Z-2992-2024Class IIOngoingVoluntary: Firm initiated
Z-2993-2024Class IIOngoingVoluntary: Firm initiated
Z-2994-2024Class IIOngoingVoluntary: Firm initiated
Z-2995-2024Class IIOngoingVoluntary: Firm initiated
Z-2996-2024Class IIOngoingVoluntary: Firm initiated
Z-2997-2024Class IIOngoingVoluntary: Firm initiated
Z-2998-2024Class IIOngoingVoluntary: Firm initiated
Z-2999-2024Class IIOngoingVoluntary: Firm initiated
Z-3000-2024Class IIOngoingVoluntary: Firm initiated
Z-3001-2024Class IIOngoingVoluntary: Firm initiated
Z-3002-2024Class IIOngoingVoluntary: Firm initiated
Z-3003-2024Class IIOngoingVoluntary: Firm initiated
Z-3004-2024Class IIOngoingVoluntary: Firm initiated
Z-3005-2024Class IIOngoingVoluntary: Firm initiated
Z-3006-2024Class IIOngoingVoluntary: Firm initiated
Z-3007-2024Class IIOngoingVoluntary: Firm initiated
Z-3008-2024Class IIOngoingVoluntary: Firm initiated
Z-3009-2024Class IIOngoingVoluntary: Firm initiated
Z-3010-2024Class IIOngoingVoluntary: Firm initiated
Z-3011-2024Class IIOngoingVoluntary: Firm initiated
Z-3012-2024Class IIOngoingVoluntary: Firm initiated
Z-3013-2024Class IIOngoingVoluntary: Firm initiated
Z-3014-2024Class IIOngoingVoluntary: Firm initiated
Z-3015-2024Class IIOngoingVoluntary: Firm initiated
Z-3016-2024Class IIOngoingVoluntary: Firm initiated
Z-3017-2024Class IIOngoingVoluntary: Firm initiated
Z-3018-2024Class IIOngoingVoluntary: Firm initiated
Z-3019-2024Class IIOngoingVoluntary: Firm initiated
Z-3020-2024Class IIOngoingVoluntary: Firm initiated
Z-3021-2024Class IIOngoingVoluntary: Firm initiated
Z-3022-2024Class IIOngoingVoluntary: Firm initiated
Z-3023-2024Class IIOngoingVoluntary: Firm initiated
Z-3024-2024Class IIOngoingVoluntary: Firm initiated
Z-3025-2024Class IIOngoingVoluntary: Firm initiated
Z-3026-2024Class IIOngoingVoluntary: Firm initiated
Z-3027-2024Class IIOngoingVoluntary: Firm initiated
Z-3028-2024Class IIOngoingVoluntary: Firm initiated
Z-3029-2024Class IIOngoingVoluntary: Firm initiated
Z-3030-2024Class IIOngoingVoluntary: Firm initiated
Z-3031-2024Class IIOngoingVoluntary: Firm initiated
Z-3032-2024Class IIOngoingVoluntary: Firm initiated
Z-3033-2024Class IIOngoingVoluntary: Firm initiated
Z-3034-2024Class IIOngoingVoluntary: Firm initiated
Z-3035-2024Class IIOngoingVoluntary: Firm initiated
Z-3036-2024Class IIOngoingVoluntary: Firm initiated
Z-3037-2024Class IIOngoingVoluntary: Firm initiated
Z-3038-2024Class IIOngoingVoluntary: Firm initiated
Z-3039-2024Class IIOngoingVoluntary: Firm initiated
Z-3040-2024Class IIOngoingVoluntary: Firm initiated
Z-3041-2024Class IIOngoingVoluntary: Firm initiated
Z-3042-2024Class IIOngoingVoluntary: Firm initiated
Z-3043-2024Class IIOngoingVoluntary: Firm initiated
Z-3044-2024Class IIOngoingVoluntary: Firm initiated
Z-3045-2024Class IIOngoingVoluntary: Firm initiated
Z-3046-2024Class IIOngoingVoluntary: Firm initiated
Z-3047-2024Class IIOngoingVoluntary: Firm initiated
Z-3048-2024Class IIOngoingVoluntary: Firm initiated
Z-3049-2024Class IIOngoingVoluntary: Firm initiated
Z-3050-2024Class IIOngoingVoluntary: Firm initiated
Z-3051-2024Class IIOngoingVoluntary: Firm initiated
Z-3052-2024Class IIOngoingVoluntary: Firm initiated
Z-3053-2024Class IIOngoingVoluntary: Firm initiated
Z-3054-2024Class IIOngoingVoluntary: Firm initiated
Z-3055-2024Class IIOngoingVoluntary: Firm initiated
Z-3056-2024Class IIOngoingVoluntary: Firm initiated
Z-3057-2024Class IIOngoingVoluntary: Firm initiated
Z-3058-2024Class IIOngoingVoluntary: Firm initiated
Z-3059-2024Class IIOngoingVoluntary: Firm initiated
Z-3060-2024Class IIOngoingVoluntary: Firm initiated
Z-3061-2024Class IIOngoingVoluntary: Firm initiated