Recall Z-0984-2017 ยท KMJ Lubricant, Patient
MEDLINE IND
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
| Date | Dec 12, 2016 |
| Status | Terminated |
| Reason | Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company. |
| Root cause | Process control |
| Action | Medline Industries sent a recall notification letters dated December 12, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to quarantine any affected product on hand and return product to Medline Industries for credit. Distributors were instructed to notify their customers and have them return affected product as well. For questions contact 866-359-1704. |
| Quantity | 12,024 tubes |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041060 | E-Z LUBRICATING JELLY Chester Labs, Inc., May 7, 2004 |