510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2750-2024Class II

Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, 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 procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF... 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-2750-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000; 2) BREAST, Pack Number DYNJ902703K; 3) ENT TYMPANOPLASTY PACK-LF , Pack Number DYNJ38988J; 4)FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179A; 5) FREE FLAP TRAM ADD ON PACK, Pack Number DYNJ82179AH; 6) JSI-MUSCLE&PLASTICS PACK-LF , Pack Number DYNJ0608555P; 7) OCCULAR PLASTIC, Pack Number DYNJ901206F; 8) OCCULAR PLASTIC PACK, Pack Number CMPJ05506F; 9) OCCULOPLASTIC PACK, Pack Number DYNJ65156; 10) PLASTIC PACK, Pack Number DYNJ47842C;
Product code
FTN Plastic Surgery And Accessories 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 the 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
Product codes and lots
DYKM2000 , Lot Number: 21FBO406 DYKM2000 , Lot Number: 22DBI980 DYKM2000 , Lot Number: 22KBD028 DYKM2000 , Lot Number: 23JBC148 DYKM2000 , Lot Number: 24ABL480 DYKM2000 , Lot Number: 21ABM981 DYKM2000 , Lot Number: 21BBR866 DYNJ902703K, Lot Number: 21FBI191 DYNJ902703K, Lot Number: 21FBR340 DYNJ902703K, Lot Number: 22OBL867 DYNJ902703K, Lot Number: 22DBH342 DYNJ902703K, Lot Number: 22DBI420 DYNJ902703K, Lot Number: 22FBM439 DYNJ38988J , Lot Number: 23JDA299 DYNJ82179A , Lot Number: 23JDB728 DYNJ82179AH, Lot Number: 23JDB728 DYNJ0608555P , Lot Number: 23GMI735 DYNJ0608555P , Lot Number: 23KMC310 DYNJ901206F, Lot Number: 23IBC085 DYNJ901206F, Lot Number: 23LBA443 DYNJ901206F, Lot Number: 24ABY049 CMPJ05506F , Lot Number: 23HBM696 CMPJ05506F , Lot Number: 23KBK942 CMPJ05506F , Lot Number: 24ABM251 DYNJ65156, Lot Number: 21GDC910 DYNJ65156, Lot Number: 21JDA096 DYNJ65156, Lot Number: 22CDC307 DYNJ65156, Lot Number: 23BDC115 DYNJ65156, Lot Number: 23EDC523 DYNJ65156, Lot Number: 23GDA856 DYNJ47842C , Lot Number: 23HBV422

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2750-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2739-2024Class IIOngoingVoluntary: Firm initiated
Z-2740-2024Class IIOngoingVoluntary: Firm initiated
Z-2741-2024Class IIOngoingVoluntary: Firm initiated
Z-2742-2024Class IIOngoingVoluntary: Firm initiated
Z-2743-2024Class IIOngoingVoluntary: Firm initiated
Z-2744-2024Class IIOngoingVoluntary: Firm initiated
Z-2745-2024Class IIOngoingVoluntary: Firm initiated
Z-2746-2024Class IIOngoingVoluntary: Firm initiated
Z-2747-2024Class IIOngoingVoluntary: Firm initiated
Z-2748-2024Class IIOngoingVoluntary: Firm initiated
Z-2749-2024Class IIOngoingVoluntary: Firm initiated
Z-2750-2024Class IIOngoingVoluntary: Firm initiated
Z-2751-2024Class IIOngoingVoluntary: Firm initiated
Z-2752-2024Class IIOngoingVoluntary: Firm initiated
Z-2753-2024Class IIOngoingVoluntary: Firm initiated
Z-2754-2024Class IIOngoingVoluntary: Firm initiated
Z-2755-2024Class IIOngoingVoluntary: Firm initiated
Z-2756-2024Class IIOngoingVoluntary: Firm initiated
Z-2757-2024Class IIOngoingVoluntary: Firm initiated
Z-2758-2024Class IIOngoingVoluntary: Firm initiated
Z-2759-2024Class IIOngoingVoluntary: Firm initiated
Z-2760-2024Class IIOngoingVoluntary: Firm initiated
Z-2761-2024Class IIOngoingVoluntary: Firm initiated
Z-2762-2024Class IIOngoingVoluntary: Firm initiated
Z-2763-2024Class IIOngoingVoluntary: Firm initiated
Z-2764-2024Class IIOngoingVoluntary: Firm initiated
Z-2765-2024Class IIOngoingVoluntary: Firm initiated