Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 10, 2014
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) S
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Customed, Inc recalled CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFO… - a critical-severity action.
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFO… was recalled by Customed, Inc in September 10, 2014. Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on differen…. Check the official notice for the remedy. Verify recall #Z-2449-2014 with the FDA Devices before acting.
The recall
Customed, Inc issued this critical-severity FDA Devices recall-Customed has determined that there is the possibility that packaging integrity may be compromised on differen….
- Critical
- severity level
- Class I
- classification
- September 10, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2449-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2449-2014) was formally reported on September 10, 2014, with the manufacturer initiating the action on May 20, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Customed, Inc is listed as the recalling firm, operating out of Fajardo, PR. Federal records list the affected scope as 2 lots/160 units,(multiple units per lot).
The documented reason for this recall is: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination … Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2 lots/160 units,(multiple units per lot)
Related Recalls
6
3 from same agency
Product description
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4" (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17" X 23" (9) LABELS FOR SKIN MARKERS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Reason for recall
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2449-2014 |
| Date reported | September 10, 2014 |
| Date initiated | May 20, 2014 |
| Recalling firm | Customed, Inc |
| Firm location | Fajardo, PR |
| Affected scope | 2 lots/160 units,(multiple units per lot) |
| Distribution | Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2449-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" (1) TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP (2) GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4" (2) GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % (1) RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK (1) BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17" X 23" (9) LABELS FOR SKIN MARKERS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 2 lots/160 units,(multiple units per lot).
Why was this product recalled? ▼
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2449-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2449-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 10, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.