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Terminated

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 Recall Z-0097-2015 · Posted 2014-10-20

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeKDQ
Date Initiated2014-08-22
Date Terminated2015-04-15
Product Quantity13,900 units

Reason for Recall

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

Firm 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 [email protected] 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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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