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Terminated

SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

FDA Recall Z-1366-2021 · Posted None

Recalling FirmSharp Medical Products
Recall StatusTerminated
Product CodeGCJ
Date Initiated2021-02-08
Date Terminated2023-02-17
Product Quantity129 units (63 units for Human-use and 66 units for Non-Human use)

Reason for Recall

Non-conformity (holes/punctures or deep creases) in the sterile barrier.

Firm Action

On 02/08/2021 the firm began notifying customers and received confirmation that affected lot was still on customers shelves. On 03/03/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via certified US mail informing customers that they have become aware of product that either have holes or deep creases in the sterile barrier that makes the product unsafe for use and could lead to patient infection, sepsis, or death if used. Customer are instructed: 1.That any/all remaining units on their shelves should be disposed of in the trash. 2. Complete "MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and scan and send via email to [email protected] or send via mail to attention of Carolyn Urish at 14362 N Frank Lloyd Wright, Scottdales AZ, 85260. Any questions or further guidance - contact the Recalling Firm at email [email protected] or by phone at 630-232-8002 ext. 5 Monday through Friday 8:00 a.m. to 4:30 p.m. Mountain Time.

Root Cause

Under Investigation by firm

Distribution Pattern

U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None

Official Source

View FDA Recall →

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

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