The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1474-2022·Announced 2022-08-03

Medline Convenience Surgical Kits Recalled Due to Leaking Isopropyl Alcohol

Medline Convenience surgical kits containing leaking bottles of isopropyl alcohol are being recalled nationwide. The leaking alcohol poses a risk of chemical exposure to healthcare workers and potential contamination of the surgical field.

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: This is an FDA Class II recall of medical surgical kits with no reported illnesses or injuries. The hazard—leaking isopropyl alcohol—presents a risk of chemical exposure to healthcare workers and surgical field contamination, qualifying as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Convenience surgical kits are being recalled due to leaking bottles of isopropyl alcohol contained within the kits. The recall affects multiple product types including Major Vascular CDS kits, Post Op Kits, Neurological Fusion kits, Pre-Op Accessory Kits, Deep Brain Stimulation Packs, Minimally Invasive Packs, EVLP Packs, General Purpose CV kits, Germantown CABG kits, Dental Restoration packs, Alcohol Prep Packs, and Matrixectomy Packs. Approximately 6,569 units have been distributed nationwide.

The leaking isopropyl alcohol presents a risk of chemical exposure to healthcare workers who handle or open the kits, and poses a potential risk of contamination to the surgical field during medical procedures where these kits are used.

Healthcare facilities that have received these recalled kits should identify the affected products using the model and lot numbers provided and should discontinue use immediately. Facilities should contact Medline Industries, LP - SPT for instructions on returning the products or obtaining replacements.

The recalled product

Product
Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i.…
Manufacturer
MEDLINE INDUSTRIES, LP - SPT
Category
Medical Device — Surgical kits
Hazard
Affected units
6,569

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)

  • Lot Code: a. Model Number CDS981543D
  • Lot Numbers: 19HBK745
  • b. Model Number DYKM1875
  • Lot Numbers: 22ABK810
  • 22ABO583
  • 21LBB378
  • c. Model Number DYKMBNDL142A
  • Lot Numbers: 22OBJ742
  • 22ABY101
  • 21FBQ232
  • 21HBG594
  • 21JBA902
  • 21VBC259
  • 21DBE917
  • d. Model Number DYKS1185A
  • Lot Numbers: 21LBX041
  • 22CBO060
  • 21HBI534
  • 21HBQ840
  • 21CBT064

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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