CLASS I Device recall · Reported 10 Sep 2014 · FDA Enforcement Report
Laminectomy Pack - ( I) Ring Basin Lif Table Cover recalled by Customed
Customed is recalling Laminectomy Pack - ( I) Ring Basin Lif Table Cover Reinforced 50" X 90" Lif ( I) Skin, distributed nationwide in the US. The recall was initiated on 20 May 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2379-2014
- FDA event ID
- 68536
- Recalling firm
- Customed, Fajardo, PR
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 May 2014
- FDA classified
- 29 Aug 2014
- Reported
- 10 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 20 May 2014 | Recall initiated by company | |
| 29 Aug 2014 | Classified by FDA | +101 days |
| 10 Sep 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16oz. LIF ( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP (6) ABSORBENT TOWEL I5" X 20" LIF ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF ( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41" X 69" MEDIUM LIF (2) LEGGING W/7'' CUFF 30" X 42" LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR ( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF ( I) PVP SCRUB 8" STICK SPONGE ( I) MAYO TRAY LARGE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL (2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL ( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF ( I) PVP PAINT 8" STICK SPONGE ( I) SURGICAL STRIP W' X 6" COTTON (2) LITE GLOVES LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Where it was distributed
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.
Questions about this recall
Is Laminectomy Pack - ( I) Ring Basin Lif Table Cover Reinforced 50" X 90" Lif ( I) Skin recalled?
Yes. Customed recalled Laminectomy Pack - ( I) Ring Basin Lif Table Cover Reinforced 50" X 90" Lif ( I) Skin on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2379-2014.
Why was it 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 lots are affected?
Product code 900-1202, 12 lots: 112051738 113078681 113099269 113109712 131110160 131210629 140111078 140211462 140211633 140311918 140412586 140513335
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Customed
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|---|---|---|---|---|---|
| Device | CLASS II | Catalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalled | Customed | Sterility | PR |
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| Device | CLASS II | Catalog Number: 9001933 Ophtalmic Surgical Pack Used recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 900169 Universal Surgical Pack Used by medical staff recalled | Customed | Sterility | PR |
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