The Recall Desk
HighFDA (Devices)·Z-2168-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barrier

Medline is recalling multiple probe cover kits used in diagnostic ultrasound and vascular access procedures due to inadequate barriers at the seams. No illnesses or injuries have been reported.

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 medical device recall involving a structural defect (inadequate seam barrier) in probe covers used in sterile diagnostic and vascular procedures. Although no illnesses or injuries have been reported, the defect poses a potential contamination risk, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling multiple probe cover kit models containing sterile ultrasound gel used in diagnostic ultrasound procedures and vascular access interventions. The recall includes over 75 different kit models, distributed worldwide between December 2017 and May 2023, affecting approximately 3.7 million units.

The probe covers have an inadequate barrier at the seams, which could potentially allow contamination during sterile procedures. The FDA classifies this as a Class II recall. No illnesses or injuries have been reported to date.

The affected products were distributed worldwide, including in the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. Healthcare facilities should identify affected kits in their inventory using the model numbers and UDI codes provided in the detailed recall notice.

Healthcare providers should stop using the affected probe cover kits immediately. Contact Medline Industries directly for instructions on returning the products and obtaining replacements.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER P
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound probe covers and vascular access kits
Hazard
  • barrier-defect
  • 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 (EA) 10193489212143
  • UDI/DI (CS) 40193489212144
  • b) Model Number DYNJ64725B
  • UDI/DI (EA) 10193489452846
  • UDI/DI (CS) 40193489452847
  • c) Model Number DYNJ65560C
  • UDI/DI (EA) 10195327136819
  • UDI/DI (CS) 40195327136810
  • d) Model Number DYNJ65775
  • UDI/DI (EA) 10193489289824
  • UDI/DI (CS) 40193489289825
  • e) Model Number DYNJ65827
  • UDI/DI (EA) 10193489298499
  • UDI/DI (CS) 40193489298490
  • f) Model Number DYNJ65838
  • UDI/DI (EA) 10193489303261
  • UDI/DI (CS) 40193489303262
  • g) Model Number DYNJ66062
  • UDI/DI (EA) 10193489319217

Distribution

Distributed nationwide across the United States.

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