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U.S. Department of Health and Human Services

Class 2 Device Recall First Step Flexible Endoscope Bedside PreClean Kit, EP4.

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 Class 2 Device Recall First Step Flexible Endoscope Bedside PreClean Kit, EP4.see related information
Date Initiated by FirmNovember 03, 2017
Create DateMarch 26, 2018
Recall Status1 Terminated 3 on July 17, 2018
Recall NumberZ-1182-2018
Recall Event ID 79402
Product Classification Accessories, cleaning brushes, for endoscope - Product Code MNL
ProductFirst 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.".
Code Information EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A 
FEI Number 3001451466
Recalling Firm/
Manufacturer		 Madison Polymeric Engineering
965 W Main St
Branford CT 06405-3453
For Additional Information ContactCathey Szeto
203-488-4554 Ext. 105
Manufacturer Reason
for Recall		Affected lots may have exceeded its microbial limits.
FDA Determined
Cause 2		Process design
ActionCygnus 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.
Quantity in Commerce285 cases
DistributionUS Distribution. .
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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