The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1470-2022·Announced 2022-08-03

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer
MEDLINE INDUSTRIES, LP - SPT
Category
Medical Device — Medical Convenience Kits
Hazard
Affected units
1,960

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.

Part of a larger recall action

This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - SPT under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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