Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx On

FDA device recall Z-0097-2015 · posted 2014-10-20 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

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.

Root cause

Process control

Status

Terminated

Product code

KDQ

Quantity affected

13,900 units

Distribution

Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY

Date initiated

2014-08-22

Date posted

2014-10-20

Date terminated

2015-04-15

Location

Powell, TN