Recall record at a glance
| Official record | Z-2364-2014 |
|---|---|
| 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 | 34 lots; 3603 units (multiple units per lot) |
| Location | Fajardo, PR, United States |
Official product description
LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF (1) LITE GLOVE LIF (1) BAG SUTURE FLORAL (1) BLADE SURGICAL #1 0 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CAUTERY TIP POLISHER LIF (1) BAG GLASSINE (1) TABLE COVER 44" X 90" L/F (2) DRAPE SHEET 41 " X 58" SMS (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) TUBE SUCTION CONECT W' X 12' LIF (3) ABSORBENT TOWELS 15" X 20" LIF (1) CAUTERY PENCIL PUSH BOTTON (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF 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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.