Recall record at a glance
| Official record | Z-2528-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Customed, Inc. |
| Report date | Sep 10, 2014 |
| Recall initiation date | May 20, 2014 |
| Quantity | 4 lots/ 154 units, multiple units per lot |
| Location | Fajardo, PR, United States |
Official product description
Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (3) LITE GLOVE LIF (1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" (1) BLADE SURGICAL# 11 (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SUTURE BAG FLORAL L/F (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF (1) CABLE LAP 10FR 4MM MALE MONOP. LIF (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (1) WRAPPER 24" X 24" LIF (1) ULTRA VERES NEEDLE 120MM LIF (1) TROCAR ENDO.XCELL DILATING TIP 11 MM (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF (1) CANNULA 5MM XCEL SLEEVES LIF (2) DENTURE CUP 8oz W/LID (2) DRESSING NON ADH TELFA 4" X 3" (1) CHLORAPREP 26ML APPLICATOR TEAL LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Why the product was 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.
Distribution information
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 to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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