The Recall Desk
HighFDA (Devices)·Z-2177-2023·Announced 2023-07-26

Medline Probe Cover Kits recalled for inadequate seam barriers

Medline is recalling 4,398 probe cover kits used in ultrasound procedures due to inadequate seam barriers that may compromise sterility. The kits were distributed worldwide from December 2017 through May 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 of a medical device used in sterile procedures with potential risk of compromising sterility. However, no illnesses or injuries have been reported, placing this in the risk-of-harm-without-reported-injury category, which yields a maximum severity score of 3 per the rubric.

Plain-English summary

Medline Industries, LP is recalling multiple models of probe cover kits that contain sterile ultrasound gel. Twenty distinct model numbers are affected, including variants labeled as breast packs, facial procedure packs, plastic packs, and other surgical procedure kits.

The probe covers may have inadequate barriers at the seams. An inadequate barrier could compromise the sterility of the field during diagnostic ultrasound procedures, creating a pathway for contamination during sterile medical procedures.

The recall affects 4,398 units of affected kits distributed worldwide, including the United States (nationwide) and ten foreign countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected kits were distributed between December 2017 and May 2023 and include products still within their expiration dates. Detailed model numbers and UDI (Unique Device Identification) codes are available in the complete FDA recall notice.

The FDA has classified this as a Class II recall. No illnesses or injuries have been reported in association with this defect.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FAC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound Equipment
Hazard
  • inadequate-barrier
  • contamination-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 (20)

  • all lots within expiry
  • UDI/DI 10889942771523
  • UDI/DI 40889942771524
  • b) Model Number DYNDH1389B
  • UDI/DI 10193489449181
  • UDI/DI 40193489449182
  • c) Model Number DYNJ35262A
  • UDI/DI 10193489903430
  • UDI/DI 40193489903431
  • d) Model Number DYNJ39508A
  • UDI/DI 10889942628919
  • UDI/DI 40889942628910
  • e) Model Number DYNJ55954C
  • UDI/DI 10193489855791
  • UDI/DI 40193489855792
  • f) Model Number DYNJ63893
  • UDI/DI 10193489771565
  • UDI/DI 40193489771566
  • g) Model Number DYNJ63893A
  • UDI/DI 10195327316891

Distribution

Distributed nationwide across the United States.

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