Recall Z-0097-2015 ยท KDQ Bottle, Collection, Vacuum
DeRoyal Industries Inc
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
| Date | Oct 20, 2014 (initiated Aug 22, 2014) |
| Status | Terminated |
| Reason | These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. |
| Root cause | Process control |
| Action | DeRoyal sent an Urgent Voluntary Recall letter dated August 22, 2014, to all affected consignees by overnight letter or by email. DeRoyal was to follow up with non-responding accounts before October 1, 2014. Customers were instructed to check their inventory for the affected product. If they have affected product, customers were instructed to destory both the liner and the lid and dispose of it according to their facility's procedures. Customers were instructed to return the included Notice of Destruction to recalls@deroyal.com even if they no longer have affected product. Customers with |
| Quantity | 13,900 units |
| Distribution | Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.