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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68952

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

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Event summary

Timeline bucket
July 15, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Vascutek, Ltd.

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

Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

Z-2266-2014
Recall number
Z-2266-2014
Initiated
July 15, 2014
Classification
Class II
Status
Terminated
Recalling firm
Vascutek, Ltd.
Quantity
63,162

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).

Code information

731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL

Distribution pattern

Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.