FDAFDA · Food and drugs·Recall number Z-2144-2017
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Published May 31, 2017 · Recall initiated: April 21, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- Nationwide Distribution
- Lot
- Catalog Number: SU130-1311 Lot Numbers: 1161247 1161248 1161249 1161250 1161251 1161252 1161414 1161415 1161416 1161417 1161418 1161419 1161420 1161421 1161509 1161510 1161511 1161512 1161513 1161514 1161515 1161622 1161623 1161624 1161625 1161626 1161627 1161628 1170089 1170094 1170095 1170096 1170353 1170354 1170356
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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