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 contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".
This recall has been terminated (originally issued November 3, 2017).
- Company
- Madison Polymeric Engineering
- Recall Initiated
- November 3, 2017
- Terminated
- July 17, 2018
- Recall Number
- Z-1182-2018
- Quantity
- 285 cases
- Firm Location
- Branford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Affected lots may have exceeded its microbial limits.
Distribution
US Distribution. .
Lot / Code Info
EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
Root Cause
Process design
Action Taken
Cygnus sent an Recall Letter dated November 3, 2017. Actions Required: 1. Immediately discontinue distribution of First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable). 2. Determine if any stock of the First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable) remains in your inventory. 3. Please complete the attached form and return to Cygnus Medical as indicated. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received the lots in the tables above between November 28, 2016 and January 11, 2017 with the letter provided. Once Cygnus Medical has received your completed form, if you have indicated you have any remaining product from these lots, we will issue a Return Goods Authorization, call tag, and/or FedEx/UPS account number. If you have questions regarding this matter, please contact Customer Service at 800-990-7489 or Quality Control at 203-488-4554 at x105 during business hours 8:30am-5:00pm Eastern Standard Time.