Class 1 Device Recall Sterile Water/Saline (2024)

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Class 1 Device Recall Sterile Water/Saline

Date Initiated by Firm	November 06, 2023
Date Posted	December 20, 2023
Recall Status1	Open3, Classified
Recall Number	Z-0513-2024
Recall Event ID	93434
510(K)Number	K083042
Product Classification	Dressing, wound, drug - Product Code FRO
Product	Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT00103427; COVIDIEN: STERILE WOUND SOLUTION/90SAL, STERILE WOUND SOLUTION/210SAL; HAYLARD OWENS MINOR: 250ML STERILE WATER BOTTLE/49148, 250ML STERILE SALINE BOTTLE/49152, 1000ML STERILE SALINE BOTTLE/49154, 100ML STERILE SALINE BOTTLE/49155, 1000ML STERILE WATER BOTTLE/49150, 100ML STERILE WATER BOTTLE/49151, 500ML STERILE WATER BOTTLE/49149, 500ML STERILE SALINE BOTTLE/49153; IDEXX: BOTTLE STERILE WATER 10 PACK/98-09444-01; MCKESSON: 100ML STERILE SALINE BOTTLE/37-6240, 500ML STERILE WATER BOTTLE/37-6290, 250ML STERILE SALINE BOTTLE/37-6270, 500ML STERILE SALINE BOTTLE/37-6280, 120ML STERILE WATER CUP/37-6210, 1000ML STERILE SALINE BOTTLE/37-6281, 1000ML STERILE WATER BOTTLE/37-6291, 120ML STERILE SALINE CUP/37-6220, 100ML STERILE WATER BOTTLE/37-6250, 250ML STERILE WATER BOTTLE/37-6260, 210ML SALINE WOUND FLUSH/37-6507, 88.7ML SALINE WOUND FLUSH STERILE/37-6503; MEDICHOICE OWENS MINOR: CAN STERILE SALINE SPRY MEDI 7.1 OZ/SWF071; MEDLINE: 110ML STERILE SALINE CUP/DYND40540, 100ML STERILE SALINE BOTTLE/RDI30296, 250ML STERILE WATER BOTTLE/PCS1550, 250ML STERILE SALINE BOTTLE/PCS1650, 1000ML STERILE SALINE BOTTLE/DYND1000MLS, 100ML STERILE SALINE BOTTLE/52011, 500ML STERILE WATER BOTTLE/DYND500MLW, 500ML STERILE SALINE BOTTLE/DYND500MLS, 100ML STERILE WATER BOTTLE/RDI30295, CAN SALINE STERILE SPRAY CURAD/CURSALINE7, 110ML STERILE WATER CUP/DYND40570, 100ML STERILE WATER BOTTLE/54380; NURSE ASSIST: 100ML STERILE SALINE BOTTLE/6492775, 100ML STERILE WATER BOTTLE/6492776; STERICARE: 90ML USP SALINE WOULD FLUSH/6503, 100ML STERILE SALINE BOTTLE/6240, 100ML STERILE WATER BOTTLE/6250, 250ML STERILE SALINE BOTTLE/6270, 500ML STERILE WATER BOTTLE/6290, 250ML STERILE WATER BOTTLE/6260, 500ML STERILE SALINE BOTTLE/6280, 1000ML STERILE SALINE BOTTLE/6281, 1000ML STERILE WATER BOTTLE/6291, 210ML SALINE WOUND FLUSH/6507, 120ML STERILE SALINE FOIL LID CUP/6220, 120ML STERILE WATER FIOL LID CUP/6210, 500ML STERILE WATER BOTTLE/5290, 500ML STERILE SALINE BOTTLE/5280; VYAIRE: CUP STERILE SALINE FOIL LID 120 ML/4873C
Code Information	Product Code/UDI-DI/Lot: 1020/50192253044490/21122619, 22063546, 22094023, 22094028, 22094074, 22094095, 22104138, 23045320, 23076080;1022/50192253044506/22012651, 22063553, 22083775, 22093943, 22094062, 22104137, 23045338, 23076038, 23076088;1024/50192253044513/21122618, 22073561, 22093989, 22094122, 23034994, 23045174, 23076031, 23076098;10000/50192253044520/22073713, 22094086, 22104147, 22104279, 23076079;PT00103419/50192253044513/23076122;PT00103427/50192253044506/23076140, 23086258;90SAL/20884521140940/22083848;210SAL/10884521139756/22022771, 22022776, 22114334;49148/20885632395878/23076067;49152/20885632395915/23076041;49154/20885632395939/23076066;49155/20885632395946/23076057;49150/20885632395892/23076074;49151/20885632395908/23076040;49149/20885632395885/2308616349153/20885632395922/23086156;98-09444-01/21112440, 22032932, 22083886, 22104140, 22114339, 22114360, 23065971, 23096487;37-6240/612479168565/21112357, 21122528, 21122548, 21122575, 21122592, 22012685, 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Recalling Firm/ Manufacturer	Nurse Assist, LLC 4409 Haltom Rd Haltom City TX 76117-1207
For Additional Information Contact	Michelle Smith 800-649-6800 Ext. 120
Manufacturer Reason for Recall	Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
FDA Determined Cause 2	Process control
Action	On 11/6/23, the firm issued a press release.On 11/09/23, "URGENT: MEDICAL DEVICE RECALL" notices and response forms were emailed and mailed to direct customers and distributors, who were provided with a separate customer recall notice they could forward to their customers. Customers were asked to do the following:1) Quarantine and then return affected devices.2) If affected products were further distributed, send these customers the attached recall notice that asks customers to return affected devices to their distributors.3) Distributors are asked to follow up with customers to ensure they received the recall notification and are taking appropriate action.4) Distributors are asked to provide their Customer Shipment Report that lists all devices shipped to customers. The report should include the Shipment Date, Customer Name and Address, Part Number, Lot Number, and Quantity. This information is important to determine removal effectiveness.5) Complete and return the response form via email to nurseassist@rqa-inc.com 6) If your company repacked these medical devices into convenience kits, please contact your local FDA recall coordinator to evaluate the need for a new recall.The firm is arranging for removal and replacement of the affected product.The recall notice sent by distributors to their customers also asks that the notice be forwarded to the applicable personnel in their organization or to any organization where the Affected Devices were transferred. Customers with questions can call 800-649-6800, between the hours of 8am and 4:30pm (CST), or email productremovalinfo@nurseassist.com
Quantity in Commerce	31,850 Cases
Distribution	US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY.OUS (foreign) distribution to: Canada
Total Product Life Cycle	TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database	510(K)s with Product Code = FRO and Original Applicant = NURSE ASSIST, INC.

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