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Terminated

EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F

FDA Recall Z-2208-2020 · Posted None

Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeMSD
Date Initiated2019-06-14
Date Terminated2024-09-18
Product Quantity215

Reason for Recall

Incorrect Peel-Apart Introducer Sheath in Kit.

Firm Action

On 06/14/2019, an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to each of the US consignees via FedEx with proof of delivery notification.

Root Cause

Error in labeling

Distribution Pattern

67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090901ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8Osmetech Molecular Diagnostics · 2009-07-06

Official Source

View FDA Recall →

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

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