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Terminated

Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

FDA Recall Z-0360-2014 · Posted 2013-11-19

Recalling FirmSALTER LABS
Recall StatusTerminated
Product CodeCCK
Date Initiated2013-11-01
Date Terminated2013-12-17
Product Quantity91 cases (25 units per case)

Reason for Recall

It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.

Firm Action

Salter Labs called the five customers that received product from the three lots, then follow-up immediately by sending a recall notification letter directly to each customer. Each letter will identify all shipments of subject product that they received. All customers letters were sent certified mail, return receipt requested.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K894350SALTER LABS MODEL #4009 SAMPLE LINESSalter Labs · 1989-10-03

Official Source

View FDA Recall →

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

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