The Recall Desk
HighFDA (Devices)·Z-2321-2023·Announced 2023-08-09

Medline Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure

Medline is recalling 233,638 procedural kits containing Turkuaz ultrasound gel that may not meet sterility specifications. The potentially non-sterile gel could pose infection risks during medical procedures.

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 a Class II recall of medical device procedural kits with a potential sterility defect. No reported illnesses or injuries are mentioned in the source. The hazard is theoretical—potential failure to meet sterility specifications—not confirmed contamination, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling 233,638 sterile and non-sterile procedural kits that contain Turkuaz ultrasound gel. The affected products include various specialized procedural kits used in medical procedures such as catheterizations, vascular interventions, ultrasound-guided procedures, and surgical preparations. The kits are identified by numerous model numbers and UPC codes, with distributions spanning from April 1, 2020, through April 28, 2023.

The recall was initiated due to a potential for the labeled sterile ultrasound gel component within the kits to not meet sterility specifications. While the gel is labeled as sterile, it may not actually be adequately sterilized, potentially allowing microbial contamination and increasing the risk of infection when these kits are used in medical procedures.

These kits have been distributed worldwide, including throughout the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. The affected products have been used in hospitals, surgical centers, and other healthcare facilities that rely on Medline's procedural kits.

Healthcare providers and facilities using these procedural kits should verify whether their stock includes any of the affected model numbers listed in the recall notice. Products identified as affected should be removed from use pending receipt of replacement stock. Further information regarding affected products and replacements can be obtained through the FDA or by contacting Medline Industries directly.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
Hazard
  • sterility-failure

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)

  • UPC Number: 088994292536. b. Model Number: DYNJ40306A
  • UPC Number: 088994260192. c. Model Number: DYNJ0774759P
  • UPC Number: 019532724613. d. Model Number: DYNJ902261D
  • UPC Number: 088994275524. e. Model Number: DYNJRA1747
  • UPC Number: 019348946400. f. Model Number: DYNJ44960D
  • UPC Number: 019348983324. g. Model Number: DYNDV2285
  • UPC Number: 019348919454
  • Model Number: MNS9865
  • UPC Number: 065316029443. h. Model Number: DYNJ904401B
  • UPC Number: 019348968343. i. Model Number: DYNJ42262D
  • UPC Number: 088994269795. j. Model Number: DYNJ47502B
  • UPC Number: 019348964922. k. Model Number: DYNJ67414
  • UPC Number: 019348996464. l. Model Number: PHS41739A
  • UPC Number: 088994290680. m. Model Number: DYNJ60038
  • UPC Number: 088827779327. n. Model Number: CDS982858F
  • UPC Number: 088827773921. o. Model Number: DYNJ39885A
  • UPC Number: 088994253993. p. Model Number: DYNJ41873B
  • UPC Number: 019348956306. q. Model Number: DYNJ52688A
  • UPC Number: 088994284356. r. Model Number: CDS982859F
  • UPC Number: 088827773920. s. Model Number: DYNJ47717

Distribution

Distributed nationwide across the United States.

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