—#130223

Product

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

FDA product code: KDQ — Bottle, Collection, Vacuum
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

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

Timeline

Recall initiated: 2014-08-22
Posted by FDA: 2014-10-20
Terminated: 2015-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130223. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.