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Terminated

BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer Push Button Blood Collection Set with the needle protector removed prior to needle retraction.

FDA Recall Z-0193-2020 · Posted None

Recall StatusTerminated
Product CodeFMI
Date Initiated2019-07-31
Date Terminated2020-07-27
Product Quantity1735600 units

Reason for Recall

Separation of front and rear barrels upon activation of the safety feature that retracts the needle

Firm Action

1. Immediately review your inventory for Catalog# 368656 with the lot numbers listed. Return all product subject to recall according to the Packing Instructions enclosed. 2. Identify all your customers that purchased affected lots of Catalog #368656, as listed . E-mail an excel file listing of all customers with their email addresses to [email protected], within 72 hours of receipt of this letter so that BD may notify these customers directly. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your credit accordingly. Please note that this is in addition to providing the customer list For any question please contact Customer/Technical Support: 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT)

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution including the states of CT, FL, MO, TN, OH, TX, GA, NC, SC, IN, IL, PA, CO and countries of Trinidad and Tobago, Hong Kong.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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