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Terminated

18G Catheter is a component in various kits.

FDA Recall Z-1133-04 · Posted 2004-07-22

Recalling FirmBraun,B Medical Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2004-04-16
Date Terminated2004-09-14
Product Quantity1176 units

Reason for Recall

Catheter separated from the hub.

Firm Action

The recalling firm issued a recall notification letter on March 19, 2004 to their direct accounts. The letter identified the problem and instructs the direct account to destroy individual units but return unopened cases to the recalling firm.

Root Cause

Other

Distribution Pattern

The units were sent to medical facilities in the following states, as listed: CA, CO, DC, FL, GA, IL, LA, MA, MI, MD, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WI, WV The product was also distributed to the following foreign accounts located in Germany, Japan, Puerto Rico, and South America.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971085SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETERB.Braun Medical, Inc. · 1997-06-02K961745BRAUN PERCUTANEOUS INTRODUCER SETB.Braun Medical, Inc. · 1996-09-17

Official Source

View FDA Recall →

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

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