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Open, Classified

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

FDA Recall Z-1457-2022 · Posted None

Recalling FirmDavol, Inc.
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2022-06-27
Product Quantity9420 (9337 in US; 83 OUS)

Reason for Recall

The device may potentially cause a fire, leading to a safety risk.

Firm Action

On June 27, 2022, the firm notified customers of the recall through Urgent Medical Device Recall letters. Customers were instructed to immediately identify and destroy all remaining product in your possession. BD will issue credit to customers who purchased the product from BD. If the customer purchased the product from a Distributor, contact your distributor for further instructions and credit resolution. If you have further questions about this recall, contact the firm: Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada and Chile.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005Davol, Inc. · 2000-12-22

Official Source

View FDA Recall →

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

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