The Recall Desk
HighFDA (Devices)·Z-2335-2023·Announced 2023-08-09

Custom Sterile Procedural Kits Recalled for Potential Sterility Specification Failure

Medline is recalling 6,340 custom sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications, creating contamination risk in surgical applications.

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: This is an FDA Class II recall of sterile medical device components with potential to not meet sterility specifications. While no illnesses or injuries have been reported in the source, the use of non-sterile equipment in surgical and procedural applications creates significant risk of contamination-related infection.

Plain-English summary

Medline Industries, LP is recalling 6,340 custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The affected kits include multiple types designed for gynecological procedures, intrauterine transfusion, neuro block procedures, PICC line placement, and other surgical applications.

The ultrasound gel component in these kits has the potential to not meet sterility specifications. This affects all lot numbers of eight different kit models distributed by Medline between April 1, 2020, and April 28, 2023.

The kits were distributed worldwide, including throughout the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.

Healthcare providers and individuals who have received or used these kits should discontinue use immediately. Those with questions or concerns should contact Medline Industries or their healthcare provider regarding potential exposure and appropriate follow-up actions.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Kits
Hazard
Affected units
6,340

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 (10)

  • UPC Number: 019348993830. b. Model Number: DYNJ906578C
  • UPC Number: 019532702355. c. Model Number: DYNJ9048708I
  • UPC Number: 019532707273. d. Model Number: PHS762887001B
  • UPC Number: 088994284931. e. Model Number: DYNJ32988
  • UPC Number: 088438924278. f. Model Number: DYNJ55361
  • UPC Number: 088994254669
  • Model Number: DYNJ55361A
  • UPC Number: 019532717352. g. Model Number: OBQ056E
  • UPC Number: 088827758937. h. Model Number: TVS4700
  • UPC Number: 081698202339.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 50 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 50 products in this recall →

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