Medline medical procedure kits recalled for dimensional variation
Medline is recalling medical procedure kits due to a slight dimensional variation that may cause fitting difficulties. No injuries or illnesses have been reported.
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: FDA Class II medical device recall where the hazard is theoretical (no injuries, illnesses, or deaths reported). The dimensional fitting issue in medical procedure kits qualifies as a risk-of-harm product category where harm has not yet been reported, placing this at the High (3) level per the rubric.
Plain-English summary
Medline Industries, LP is recalling multiple medical procedure kits due to a slight dimensional variation. The affected kits include Heart Anesthesia Setup, Endo Kits (Upper and Lower), Pacemaker Kit, and Vascular Kits, identified by their reference numbers: DYNJ902752C, DYKE1872A, DYKE1921A, DYKE1922A, DYNJ901681D, DYNJ905515D, DYNJ902387K, and DYNJS2035C.
The dimensional variation may cause increased difficulty when inserting the kits into their outer canisters. No injuries, illnesses, or deaths have been reported related to this dimensional issue.
Approximately 26,096 units have been distributed worldwide, including the entire United States and the countries of Canada, Mexico, Panama, El Salvador, Colombia, Singapore, Qatar, and Oman.
The FDA has classified this as a Class II recall. Affected products can be identified by their reference numbers and lot numbers. Individuals with these kits should refer to the official recall notice for specific lot information and contact Medline Industries for guidance.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR,
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- dimensional-variation
- improper-fit
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)
- a) REF DYNJ902752C
- UDI/DI 40195327226993 (case)
- 10195327226992 (unit)
- Lot Numbers: 22IBA627
- 22JBE922
- 22JBP917
- 22KBJ447
- 23BBB611
- 23CBC455
- 23EBF908
- 23FBV764
- 23GBW761
- 23IBR157
- b) REF DYKE1872A
- UDI/DI 40195327330027 (case)
- 10195327330026 (unit)
- Lot Numbers: 23CBB846
- 23CBK197
- 23DBK952
- 23FBD020
Distribution
Distributed nationwide across the United States.
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