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Terminated

Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.

FDA Recall Z-2242-2011 · Posted 2011-05-23

Recalling FirmSalter Laboratories, Division of Regulatory Affairs
Recall StatusTerminated
Product CodeCCK
Date Initiated2011-04-19
Date Terminated2011-08-23
Product Quantity3500 pieces

Reason for Recall

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

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

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

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