Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1353-2018Class II

First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash#...

Certified Safety Mfg Inc / initiated 2018-03-20 / Terminated

Certified Safety Mfg Inc began a recall of First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy... on . FDA classified it as Class II and gives the reason as "Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1353-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Certified Safety Mfg Inc
Product
First 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
Product code
LRR First Aid Kit With Drug
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 root cause
Other
Action
The firm initiated the recall by letter on 03/20/2018. The firm requested return of the recalled Honeywell eyewash component.
Quantity in commerce
748 units
Distribution
US 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
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1353-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1353-2018Class IITerminatedVoluntary: Firm initiated