CLASS I Device recall · Reported 10 Sep 2014 · FDA Enforcement Report
Femoral Pack Contents: Towels Absorbent 15" X 20" Lif Drape recalled
Customed is recalling Femoral Pack Contents: Towels Absorbent 15" X 20" Lif Drape Sheet 42" X 57" Sms Lif, 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-2436-2014
- 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
- Heart & Vascular Devices
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
FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57" SMS LIF (1) SAFETY IV INTROCAN 18 X 1X ST. LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP SURGICAL MAXI BLUE (1) SUTURE AID BOOT STD YELLOW ST. LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) EMESIS BASIN 101N 700cc LIF (2) LIGHT SHIELD (1) NEEDLE HYPODERMIC 18G X 1 L/F (1) CATHETER IV SAFETY 20G X 1X LIF (1) DRAPE T LAPAROT 102" X 78" X 121" SMS STD LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER I LOCK LIF (1) SUTURE BAG FLORAL LIF (2) UTILITY BOWL 16oz. L/F (1) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WITH TAPE LIF (1) MAYO TRAY SMALL (1) SCALPEL SAFETY WEIGHTED #15 (1) SCALPEL SAFETY WEIGHTED #11 (2) TUBE SUCTION CONNECT X" x 12' LIF (2) NEEDLE & BLADE COUNTER, 1Oc MAG/CLEAR LIF (1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/F Product Usage: 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 Femoral Pack Contents: Towels Absorbent 15" X 20" Lif Drape Sheet 42" X 57" Sms Lif recalled?
Yes. Customed recalled Femoral Pack Contents: Towels Absorbent 15" X 20" Lif Drape Sheet 42" X 57" Sms Lif on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2436-2014.
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 900-2164, 11 lots 112041224 112083167 113036762 113047217 113067914 113078468 113088852 131210646 140312118 140412645 140513125
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
All 682| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Catalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 9002940 Obstetrical Surgical Pack Used by medical recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 900010 Suture Removal KIT Used by medical staff to recalled | Customed | Sterility | PR |
| 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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| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |