Accessories, Cleaning Brushes, For Endoscope

Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010

During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.

Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS)

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following:

There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.

Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z

The product is contaminated with Pseudomonas.

First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross c

Affected lots may have exceeded its microbial limits.

MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.

MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW

Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.