Palindrome 8888119371Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

64 other recalls cover devices cleared under the same FDA submission (K112477); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1317-2022 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112477. One submission often covers many models, so check the product and lot details in each record.

• Z-1318-2022 · Jun 8, 2022 · Open, Classified
  Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1319-2022 · Jun 8, 2022 · Open, Classified
  Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1902-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
• Z-1866-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
• Z-1860-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
• Z-1909-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
• Z-1900-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
• Z-1906-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
• Z-1884-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P
• Z-1887-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
• Z-1869-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
• Z-1877-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
• Z-1893-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
• Z-1852-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
• Z1856-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458

…and 49 more.