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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68564

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

Open FDA event record

Event summary

Timeline bucket
June 12, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medical Action Industries 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

8 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 8

Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.

Z-1950-2014
Recall number
Z-1950-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved.

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 68350, Lot numbers: 187146, 187341, 187150 & 187148, Exp. Date: 12/01/2016; Model number: 58168, Lot number: 187212, Exp. Date: 11/1/2016; Model number: 68297B, Lot number: 187196, Exp. Date: 12/1/2016 and Model number: 72851B, Lot number: 187208, Exp. Date: 12/1/2018.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

device · product 2 of 8

Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Z-1951-2014
Recall number
Z-1951-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 72347, Lot number: 187172, Exp. Date: 9/1/2015.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

device · product 3 of 8

Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Z-1952-2014
Recall number
Z-1952-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

device · product 4 of 8

Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Z-1953-2014
Recall number
Z-1953-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

device · product 5 of 8

Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Z-1954-2014
Recall number
Z-1954-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 70828, Lot number: 187176, Exp. Date: 1/1/2016.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

device · product 6 of 8

Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Z-1955-2014
Recall number
Z-1955-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

device · product 7 of 8

McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228

Z-1956-2014
Recall number
Z-1956-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 25-2685, Lot number: 187211, Exp. Date: 12/1/2016.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.

device · product 8 of 8

Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

Z-1957-2014
Recall number
Z-1957-2014
Initiated
June 12, 2014
Classification
Class II
Status
Terminated
Quantity
474 cs (9,480 ea) total for all kits involved

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile kits may have incomplete seals which might compromise

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

Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.

Code information

Model number: 68718, Lot number: 187198, Exp. Date: 12/1/2016.

Distribution pattern

Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.