Exact FDA event identifier

Event 87346

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: February 12, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: TELEFLEX MEDICAL INC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thoracic catheter is composed of Phthalate-free PVC material and is available in straight, right angle, and trocar configurations in a variety of sizes. The catheter is soft enough to prevent tissue laceration during insertion and tissue pressure necrosis due to the catheter being left in place for a period of time. The catheter is also rigid enough to facilitate insertion of the tube and to avoid obstruction by external compression or kinking.

Z-1298-2021

Recall number: Z-1298-2021
Initiated: February 12, 2021
Classification: Class II
Status: Terminated
Recalling firm: TELEFLEX MEDICAL INC
Quantity: 520 units (US only)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

Teleflex is recalling this product due to a lack of assurance of sterility.

Code information

Catalog No.: DRAC-32S. Manufacturing Lot/Serial No.: 73J2000276. GTIN: 14026704631404 (EACH)/ GTIN: 34026704631408 (CASE)

Distribution pattern

US Nationwide distribution in the states of IL, PA, FL, NJ, CT, NY, TN.