Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 119 of 138
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C
Reason: Catheters may not meet antimicrobial specification
Z-1859-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
Reason: Catheters may not meet antimicrobial specification
Z-1891-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
Reason: Catheters may not meet antimicrobial specification
Z-1860-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
Reason: Catheters may not meet antimicrobial specification
Z-1870-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
Reason: Catheters may not meet antimicrobial specification
Z-1899-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
Reason: Catheters may not meet antimicrobial specification
Z-1883-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P
Reason: Catheters may not meet antimicrobial specification
Z-1876-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
Reason: Catheters may not meet antimicrobial specification
Z-1872-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
Reason: Catheters may not meet antimicrobial specification
Z-1865-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
Reason: Catheters may not meet antimicrobial specification
Z-1901-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
Reason: Catheters may not meet antimicrobial specification
Z1855-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
Reason: Catheters may not meet antimicrobial specification
Z-1905-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
Reason: Catheters may not meet antimicrobial specification
Z-1892-2015 July 8, 2015 North Haven, CT
Boston Scientific Corporation
Class II Terminated
Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use en...
Reason: One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
Z-1941-2015 July 8, 2015 Marlborough, MA
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
Reason: Catheters may not meet antimicrobial specification
Z-1878-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
Reason: Catheters may not meet antimicrobial specification
Z-1857-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
Reason: Catheters may not meet antimicrobial specification
Z-1890-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
Reason: Catheters may not meet antimicrobial specification
Z-1910-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
Reason: Catheters may not meet antimicrobial specification
Z-1868-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
Reason: Catheters may not meet antimicrobial specification
Z-1887-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062
Reason: Catheters may not meet antimicrobial specification
Z-1858-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
Reason: Catheters may not meet antimicrobial specification
Z-1873-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
Reason: Catheters may not meet antimicrobial specification
Z-1850-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
Reason: Catheters may not meet antimicrobial specification
Z-1900-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
Reason: Catheters may not meet antimicrobial specification
Z-1869-2015 July 8, 2015 North Haven, CT