Agency classClass IIOur severity:High FDA (Devices)·Z-0124-2023·Announced 2022-11-02

Medline Pre-Op CHG Bathing Kit recalled for incorrect expiration dates

Medline is recalling 460 Pre-Op CHG Bathing Kits because the CHG solution and blood culture bottles have expiration dates that don't match the kit label. Expired components could compromise effectiveness.

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 a Class II medical device recall involving mislabeled expiration dates on critical components. Expired CHG solution and blood culture bottles could fail to function properly in pre-operative and specimen collection procedures. No adverse events are mentioned, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling the Pre-Op CHG Bathing Kit (Reorder #P164756) due to mismatched expiration dates on kit components. The CHG (chlorhexidine gluconate) solution and Bactec blood culture bottles included in the kit have expiration dates that do not match the date listed on the kit label.

Using expired components in medical procedures poses a safety concern. CHG solution loses antimicrobial effectiveness over time, and blood culture bottles may no longer maintain proper sterility. Healthcare providers who rely on the incorrect expiration date could inadvertently use expired products, potentially compromising the safety and effectiveness of pre-operative skin preparation and blood sample collection.

The recall affects 460 kits with lot numbers 22EMI516 and 22DMG491, distributed nationwide in California.

If you have been provided one of the affected kits, stop using it and contact Medline Industries for return or replacement instructions.

The recalled product

Product: MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Pre-op Bathing / Specimen Collection
Hazard: mis-labeling
expired-component
Affected units: 460

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 (4)

UDI/DI: (01)40888277983824 (case)
(01)10888277983823 (kit)
Lot Numbers: 22EMI516
22DMG491

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 5 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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