510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-3060-2024Class II

Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack...

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) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F 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-3060-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F
Product code
OJH Orthopedic Tray
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
CDS983874F , Lot Number 19JDA152 ; CDS983874F , Lot Number 19KDC441 ; CDS983874F , Lot Number 20ADB656 ; CDS983874F , Lot Number 20BDC710 ; CDS983874F , Lot Number 20EDA493 ; CDS983874F , Lot Number 20FDB761 ; CDS983874F , Lot Number 20JDC993 ; CDS983874F , Lot Number 21ADB720 ; CDS983874F , Lot Number 21DDA797 ; CDS983874F , Lot Number 21FDB765 ; CDS983874F , Lot Number 21HDA924 ; CDS983874F , Lot Number 21KDA957 ; CDS983874F , Lot Number 22BDA224 ; CDS983874F , Lot Number 22DDB013 ; CDS983874F , Lot Number 22GDA535 ; CDS983874F , Lot Number 22HDC091 ; CDS983874F , Lot Number 22JDA459 ; CDS983874F , Lot Number 23ADB076 ; CDS983874F , Lot Number 23DDA408 ; CDS983874F , Lot Number 23FDB732 ; CDS983874F , Lot Number 23IDA600 ; CDS983874F , Lot Number 23LDA901 ; CDS983874F , Lot Number 24CDA648 ; CDS984080F, Lot Number 23FBF618; CDS984080F, Lot Number 23EBN989; CDS984080F, Lot Number 23BBR987; CDS984080F, Lot Number 23ABH436; CDS984080F, Lot Number 23ABF537; CDS984080F, Lot Number 22IBR063; CDS984080F, Lot Number 22HBJ841

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-3060-2024
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