510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-3003-2024Class II

Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY...

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: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY 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-3003-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
Product code
FCG Biopsy Needle
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
DYNJ17400B, Lot Number 23ABV075; DYNJ17400B, Lot Number 23ABV141; DYNJ17400B, Lot Number 22KBA557; DYNJ17400B, Lot Number 22GBJ307; DYNJ17400B, Lot Number 22DBU457; DYNJ32049A , Lot Number 19AKB211 ; DYNJ32049A , Lot Number 19CKA247 ; DYNJ44987G , Lot Number 21FBJ607 ; DYNJ44987G , Lot Number 21IBE237 ; DYNJ44987G , Lot Number 21KBA883 ; DYNJ44987G , Lot Number 21LBO984 ; DYNJ44987G , Lot Number 22CBN087 ; DYNJ44987G , Lot Number 20BBQ959 ; DYNJ44987G , Lot Number 20FBI170 ; DYNJ44987G , Lot Number 20JBL731 ; DYNJ44987G , Lot Number 21ABF141 ; DYNJ44987G , Lot Number 21CBF976 ; DYNJ44987G , Lot Number 21DBW445 ; DYNJ66288, Lot Number 20DBE878

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-3003-2024
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