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U.S. Department of Health and Human Services

Class 1 Device Recall NURSE ASSIST

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 Class 1 Device Recall NURSE ASSISTsee related information
Date Initiated by FirmNovember 06, 2023
Date PostedDecember 20, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0515-2024
Recall Event ID 93434
510(K)NumberK030813 
Product Classification Catheter, retention type, balloon - Product Code EZL
ProductSterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010
Code Information Product Code/UDI-DI/Lot: 1030A/B1501030A4/2001155, 2003041, 2005126, 2008103, 2102502, 2102567, 2102580, 2102600, 1812001, 22032961, 22114363, 23014570; 6496722/B15064967224/21081990, 22012631, 22012674, 22012712, 22022735, 22012715, 22022790, 22022814, 22022825, 22022858, 22032880, 22032882, 22043126, 22043146, 22043168, 22053339, 22053358, 22053248, 23014630, 23034993, 23035018, 23035017, 23045235; 6496723/B15064967234/22032892, 22032931, 22043213, 22114309, 22114358, 23034943; 1030/B15010304/22032995, 23014586; 51638/B150516384/22033023, 23014632; 52333/B150523334/22033017; 1010/B15010104/22063386, 22063498, 22073735, 23014593
Recalling Firm/
Manufacturer		 Nurse Assist, LLC
4409 Haltom Rd
Haltom City TX 76117-1207
For Additional Information ContactMichelle 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
ActionOn 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 Commerce15,800 Cases
DistributionUS 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 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 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) Database510(K)s with Product Code = EZL
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