Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to

FDA device recall Z-2242-2011 · posted 2011-05-23 · Terminated

Recall details

Recalling firm

Salter Laboratories, Division of Regulatory Affairs

Reason for recall

One complaint received of product in box different from what was on label.

Action taken

Salter Laboratories sent a URGENT PRODUCT RECALL NOTIFICATION letter dated April 19, 2011, certified mail to all of the affected consignees, along with a RECALL EFFECTIVENESS CHECK FORM to acknowledge receipt of this communication. It was reported that a package labeled 1600-14, Adult Nasal Cannula actually contained a 25-foot length of tubing and has determined that additional product may have been incorrectly labeled in this manner. No illness or injury would result from this product mix-ups. Should you have any questions, please contact Salter Laboratories at 1-800-235-4203.

Root cause

Other

Status

Terminated

Product code

CCK

Quantity affected

3500 pieces

Distribution

Worldwide Distribution - USA (nationwide) and the country of South America.

Date initiated

2011-04-19

Date posted

2011-05-23

Date terminated

2011-08-23

Location

Arvin, CA