Exact FDA event identifier

Event 76327

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 23, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Covidien LLC

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

2 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 2

Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

Z-1408-2017

Recall number: Z-1408-2017
Initiated: January 23, 2017
Classification: Class II
Status: Terminated
Recalling firm: Covidien LLC
Quantity: 1,111,600 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Sterility compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility compromised due to breach in sterile barrier

Code information

Lot Numbers: 1112351 to 1609891

Distribution pattern

Nationwide

device · product 2 of 2

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

Z-1409-2017

Recall number: Z-1409-2017
Initiated: January 23, 2017
Classification: Class II
Status: Terminated
Recalling firm: Covidien LLC
Quantity: 42,750 units