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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64326

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

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Event summary

Timeline bucket
January 28, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bacterin International, 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

Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.

Z-0936-2013
Recall number
Z-0936-2013
Initiated
January 28, 2013
Classification
Class II
Status
Terminated
Quantity
15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A portion of a silicone wound drain was found to be cracked.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A portion of a silicone wound drain was found to be cracked.

Code information

005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211

Distribution pattern

13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee

Field note

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