The Recall Desk
HighFDA (Devices)·Z-2309-2023·Announced 2023-08-09

Medline Procedural Kits with Ultrasound Gel Recalled for Sterility Risk

Medline is recalling 3,431 procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.

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 involving potential sterility failure of a medical device component used in surgical procedures. The hazard poses a genuine infection risk in clinical settings. No illnesses or injuries have been reported, placing this at the high end of non-critical recalls.

Plain-English summary

Medline Industries is recalling 3,431 sterile and non-sterile procedural kits containing Turkuaz ultrasound gel. The recall is due to a potential sterility failure—the gel component that was labeled as sterile may not meet sterility specifications, creating a potential infection risk.

The affected kits include 17 different models used in surgical and procedural applications, including carotid procedures, central line insertion, thyroid surgery, and head and neck surgery. All lot numbers of the affected models distributed between April 1, 2020 and April 28, 2023 are included in this recall.

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.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Numb
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedural Kits
Hazard
  • sterility-failure
  • infection-risk

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 (17)

  • UPC Number: 088994276521. b. Model Number: DYNJ66190
  • UPC Number: 019348932219. c. Model Number: DYNJ905622C
  • UPC Number: 019348926350. d. Model Number: DYNJ901745J
  • UPC Number: 019348960482. e. Model Number: DYNJ63347A
  • UPC Number: 019348927806. f. Model Number: CDS983069G
  • UPC Number: 019348992392. g. Model Number: CDS983069I
  • UPC Number: 019532707186. h. Model Number: DYNJ47716B
  • UPC Number: 019348945453. i. Model Number: SYNJ910018A
  • UPC Number: 019348937418. j. Model Number: DYNJ67954A
  • UPC Number: 019348995714. k. Model Number: DYNJ65706
  • UPC Number: 019348928490. l. Model Number: DYNJ905340A
  • UPC Number: 019348950213. m. Model Number: DYNJ20495J
  • UPC Number: 019348956435. n. Model Number: DYNJ30245
  • UPC Number: 008019678769. o. Model Number: DYNJ43861D
  • UPC Number: 088994276328. p. Model Number: DYNJ63634A
  • UPC Number: 019532714304. q. Model Number: DYNJ44410F
  • UPC Number: 019348981154.

Distribution

Distributed nationwide across the United States.

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