Medline Procedural Kits with Defective Plastic Syringes Recalled
Medline procedural kits contain plastic syringes affected by an FDA Safety Alert. The syringes may leak or break, posing risks to patients during medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall. Although the syringes pose a risk to patient health through potential leaks and breakage during medical procedures, no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Medline Industries is recalling multiple medical procedural kits that contain plastic syringes. The affected products include kits for BOTOX administration, breast surgery, ENT procedures, plastic surgery, and ocular procedures. The syringes are affected by an FDA Safety Alert issued on March 19, 2024.
Quality issues including leaks, breakage, and other defects have been identified in the syringes. These issues may pose a risk to patient health during medical procedures.
The recalled kits have been distributed worldwide. Healthcare facilities and providers using these products should verify whether they have affected lot numbers and contact Medline Industries for guidance on handling the recalled products.
The recalled product
- 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, Pa
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- breakage
- quality-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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