Recall Z-0515-2024 ยท EZL Catheter, Retention Type, Balloon
Nurse Assist, LLC
Sterile 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
| Date | Dec 20, 2023 (initiated Nov 6, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 15,800 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030813 | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND Primary Care Solutions, Inc., May 30, 2003 |