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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65745

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

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Event summary

Timeline bucket
July 18, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aspen Surgical Products, 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

Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

Z-1988-2013
Recall number
Z-1988-2013
Initiated
July 18, 2013
Classification
Class II
Status
Terminated
Quantity
3286 boxes ( 6,353,000)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.

Code information

Product 40-2894: Lot Numbers/Expiration Date Lot Numbers/Expiration 2690-090730 2014-07 2690-111128 2016-11 2690-091207 2014-12 2690-111205 2016-12 2690-100309 2015-03 2690-29661 2017-01 2690-100407 2015-04 2690-29775 2017-01 2690-100429 2015-04 2690-120307 2017-03 2690-100505 2015-05 2690-120410 2017-03 2690-100603 2015-06 2690-120425 2017-04 2690-100607 2015-06 2690-120517 2017-05 2690-100615 2015-06 2690-120803 2017-08 2690-100617 2015-06 2690-120822 2017-08 2690-100709 2015-07 2690-120917 2017-09 2690-100728 2015-07 2690-121019 2017-10 2690-101001 2015-10 2690-121106 2017-10 2690-101101 2015-11 2690-121105 2017-11 2690-101117 2015-11 2690-121128 2017-11 2690-101221 2015-12 2690-130107 2018-01 2690-110121 2016-01 2690-130103 2018-01 2690-110201 2016-02 2690-130109 2018-01 2690-110217 2016-02 2690-130215 2018-02 2690-110223 2016-02 2690-130307 2018-03 2690-110310 2016-03 2690-130213 2018-02 2690-110328 2016-03 2690-130306 2018-03 2690-110415 2016-04 2690-130403 2018-04 2690-110426 2016-04 2690-130409 2018-04 2690-110511 2016-02 2690-130415 2018-04 2690-120804 2017-08 " Product 39-0058 (outside USA): Lot Numbers/ Expiration Date 11305 2016-05 11731 2017-03 11974 2017-08 12353 2018-04 " Product 40-2893 (outside USA): Lot Numbers/ Expiration Date 10425 2014-11 10504 2014-07 10727 2015-02 11178 2015-10 11179 2015-12 11260 2016-01 11261 2016-02 11558 2016-07

Distribution pattern

Worldwide Distribution - US Nationwide in the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England