Recall record at a glance
| Official record | Z-2404-2014 |
|---|---|
| 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 | 16 lots; 843 units (multiple units per lot) |
| Location | Fajardo, PR, United States |
Official product description
LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH POUCH (5) LAP SPONGES PREWASH XRD L/F (1) NEEDLE HYPODERMIC 18G X 1 %" (1) MAYO STAND COVER REINFORCED LIF (1) UTILITY BOWL 32oz. L/F (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (4) TOWEL ABSORBENT 15" X 20" L/F (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CLOTH HUCK TOWEL BLUE L/F (1) PVP PAINT 8" STICK SPONGE (4) DRAPE UTILITY WITH TAPE LIF (2) UTILITY BOWL 16oz LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) PVP SCRUB 8" STICK SPONGES (1) CLIPS LIGATING TIT M/L (L T 300) (4) TEGADERM 2 3/8 X 2% L/F (4) GOWN SURG. REINFORCED LARGE TOWEL/WRAP 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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