Recall Z-1040-2011 ยท KMJ Lubricant, Patient
Apogee Medical
Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
| Date | Feb 3, 2011 (initiated Jan 18, 2011) |
| Status | Terminated |
| Reason | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group. |
| Root cause | Other |
| Action | The firm, TRIAD Group, sent a "Urgent Medical Device Recall" letter dated January 18, 2010 to all consignees/customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to review there inventory, cease distribution of the affected lots and to complete and return the enclosed Product Recall Response Form via fax to 1-919-570-9611 or e-mail to Apogee Medical. If they distributed the product, they were instructed to notify their customers of the recall; to include a copy of the recall notification, and to instruct them to return |
| Quantity | see line 1. |
| Distribution | Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.