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U.S. Department of Health and Human Services

Class 2 Device Recall First aid/emergency kits containing Honeywell eyewash:

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 Class 2 Device Recall First aid/emergency kits containing Honeywell eyewash:see related information
Date Initiated by FirmMarch 20, 2018
Create DateApril 11, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall NumberZ-1353-2018
Recall Event ID 79674
510(K)NumberK941311 
Product Classification First Aid Kit with drug - Product Code LRR
ProductFirst aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet 3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 Deluxe Cabinet 3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLBCSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R 200 Person Deluxe Cabinet - Refill R508016 Eye Wash 4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet 316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36MDelmarva Power/ACEw/Logo R508016 Eye Wash4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC4 200 Person Deluxe Cabinet 4 Shelf R508016 Eye Wash4 oz. 32-000452-0000 K206140 CLX 100 Person Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV7SHStandard Cabinet Swing Out Door2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash
Code Information Lot#: Exp. Date: Description: Honeywell Part#: F15141-31 Apr-18 4 oz Eyewash Part# 32-000452-0000 F15156-21 May-18 16 oz Eyewash Part# 32-000454-0000-HS F17025-21 Jan-20 16 oz Eyewash Part# 32-000454-0000-H5 
FEI Number 1000158435
Recalling Firm/
Manufacturer		 Certified Safety Mfg Inc
1400 Chestnut Ave
Kansas City MO 64127-2023
For Additional Information ContactPam Gerson
800-854-7474
Manufacturer Reason
for Recall		Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.
FDA Determined
Cause 2		Other
ActionThe firm initiated the recall by letter on 03/20/2018. The firm requested return of the recalled Honeywell eyewash component.
Quantity in Commerce748 units
DistributionUS Nationwide Distribution in the states of NE, KY, CA, OH, TX, NC, AL, NJ, TN, MN, IA, MO, MA, MI, ME, BY, GA, WA, LA, IL, VA, NY
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.
510(K) Database510(K)s with Product Code = LRR
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