Medical Device Kits Recalled for Leaking Isopropyl Alcohol
Medline Industries is recalling medical device kits nationwide due to leaking isopropyl alcohol bottles. Approximately 28,745 units are affected. Consumers should stop using affected kits and contact the manufacturer.
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 with a chemical hazard from leaking isopropyl alcohol bottles. The leaking chemical constitutes a risk-of-harm scenario without documented reported injuries, consistent with High severity under the recall rubric.
Plain-English summary
Medline Industries, LP is recalling medical device kits that contain leaking bottles of isopropyl alcohol. The recall affects approximately 28,745 units that have been distributed nationwide in the United States.
The affected kits include multiple models, including CDS981510J, CDS984260I, CDS984263L, DYNJ906469D, DYNJ908097, DYNJ906469B, and numerous other DYNJ model variants. Each affected model has specific affected lot numbers identified in the FDA recall notice.
Leaking isopropyl alcohol in the kits presents a chemical hazard. Consumers who have received affected kits should discontinue use immediately and contact Medline Industries for instructions regarding return or replacement of the recalled products.
The recalled product
- Product
- Z-1477-2022
- Manufacturer
- MEDLINE INDUSTRIES, LP - SPT
- Category
- Medical Device
- Hazard
- chemical-leak
- chemical-exposure
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 CDS981510J
- Lot Numbers: 22BDB532
- b. Model CDS984260I
- Lot Numbers: 22CBM678
- 22CBM679
- 21FBJ127
- 21GBV813
- 21KBA497
- c. Model CDS984263L
- Lot Numbers: 22DBD966
- 22CBV297
- 21GBV822
- c. Model DYNJ906469D
- Lot Numbers: 22DDA747
- 22DDA652
- 22CDC430
- c. Model DYNJ908097
- Lot Numbers: 22ABN864
- 22BBU902
- 22BBX706
Distribution
Distributed nationwide across the United States.
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