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Terminated

ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203

FDA Recall Z-0605-2012 · Posted 2012-01-11

Recalling FirmSALTER LABS
Recall StatusTerminated
Product CodeCCK
Date Initiated2011-12-07
Date Terminated2012-01-09
Product Quantity240 cases

Reason for Recall

Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).

Firm Action

The firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- TX and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K892406MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULASalter Labs · 1989-07-24

Official Source

View FDA Recall →

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

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