Recall Z-0098-2015
DeRoyal Industries Inc · initiated August 22, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
Codes / lots: Lot 364817213
Reason for recall
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
FDA-determined cause: Process control
Action taken
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 questions were instructed to contact their DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864. For questions regarding this recall call 865-362-2334.
Details
- Recall number
- Z-0098-2015
- Initiated
- August 22, 2014
- Posted by FDA
- October 20, 2014
- Terminated
- April 15, 2015
- Product code
- KDQ – Bottle, Collection, Vacuum
- Quantity
- 5112 units
- Distribution
- Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
- Recalling firm
- DeRoyal Industries Inc, Powell, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0097-2015 Class II | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID…These lots of suction canisters and lids have an insufficient seal under low or intermittent suction… | 08/22/2014Terminated |