Medline Medical Convenience Kits Recalled for Leaking Isopropyl Alcohol Bottles
Medline is recalling medical convenience kits distributed nationwide that contain leaking bottles of isopropyl alcohol. Users should stop using the affected kits.
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 involving chemical leakage in medical convenience kits. No illnesses or injuries reported in source, but the hazard presents a risk of harm to users, meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries is recalling several models of medical convenience kits due to leaking bottles of isopropyl alcohol contained within the kits.
The recalled kits include models: BEDSIDE PICC CDS (Model CDS984642), VASCULAR CDS (Models DYNJ902880J and DYNJ902880K), OPEN HEART A & B (Model DYNJ904831F), OPEN HEART MHS (Models DYNJ905394A and DYNJ905394B), and OPEN HEART WPH (Model DYNJ908168). A total of 1,960 units were distributed across the United States.
The leaking isopropyl alcohol poses a risk to healthcare professionals and patients who use these kits. Consumers who have these kits should stop using them immediately. Affected parties should contact Medline Industries for instructions on replacement or return.
The recalled product
- Product
- Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEA
- Manufacturer
- MEDLINE INDUSTRIES, LP - SPT
- Hazard
- isopropyl-alcohol-leak
- chemical-exposure
- container-integrity-failure
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. Model Number CDS984642
- Lot codes: 19JBB553 b. Model Number DYNJ902880J
- Lot codes: 21FBR331
- 21HBD394
- 21IBP835
- 21KBM214
- 21DBE158 c. Model Number DYNJ902880K
- Lot codes: 22BBD964
- 21KBV788
- 21LBN478 e. Model Number DYNJ904831F
- Lot codes: 22DBT300
- 22DBU172
- 22BBO313
- 21JBX260
- 21KBO308 f. Model Number DYNJ905394A
- Lot codes: 21HBJ840
- 21IBU071
- 21JBY922
- 21DBS569
- 21FBA011 g. Model Number DYNJ905394B
Distribution
Distributed nationwide across the United States.
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