Recall Z-0352-2017 ยท KDQ Bottle, Collection, Vacuum
Medline Industries Inc
Rigid Suction Canister 3000 CC and 2000 CC.
| Date | Aug 10, 2016 |
| Status | Terminated |
| Reason | Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use. |
| Root cause | Process control |
| Action | Medline Industries, Inc. sent an Urgent Recall Immediate Action Required letter dated August, 23, 2016, and destruction form via first class mail to affected customers on August 17, 2016 and August 23, 2016. The firm recommended the following actions: REQUIRED ACTION: 1. Immediately check your stock for item number OR220 and OR230 with lot numbers beginning with 9961601xxxx through 9961604xxxx (listed on the original case packaging). Destroy all affected products. If the rigid canisters are NOT in the original case packaging, we are instructing you to destroy them and we will send replac |
| Quantity | 7,680 units |
| Distribution | US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.