FDA Recall Terminated

Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula. Single Patient Use. Do not Sterilize Salter Labs, 100 W. Sycamore Road, Arvin, CA 93293 Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.

Recall: Z-2237-2011 · Initiated April 19, 2011

Recall

Recall Number
Z-2237-2011
Event Number
58563
Firm
Salter Laboratories, Division of Regulatory Affairs
FEI Number
1314417
Product Code
CCK
Status
Terminated
Root Cause
Labeling mix-ups
Initiated
April 19, 2011
Posted
May 20, 2011
Terminated
August 23, 2011
Address
100 Sycamore Rd, Arvin, CA, 93203-2300

Description

Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula. Single Patient Use. Do not Sterilize Salter Labs, 100 W. Sycamore Road, Arvin, CA 93293 Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.

Reason

Complaint received that the product in the box was different from labeled product.

Action

The firm, Salter Labs, sent an "URGENT PRODUCT RECALL" subtitled Adult Divided Cannula Product Code 4707 Lot 012411, letter dated April 19, 2011 via certified mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory; return any of the lot in their possession to Salter; contact Salter Customer Service at 1-800-235-4203 to arrange for the return of the product, and complete and return the Customer Reply Form via fax to 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Distribution

Nationwide distribution.

Quantity

22,150 pieces