—#178991

Product

Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION PACK P966455A BREAST BIOPSY PACK-LF

FDA product code: PXP — Breast Biopsy / Localization Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product/Lot Number: P151659 BIOPSY TRAY 2019031490 P243133 LATEX TUBING PACK 2019042590 P243133 LATEX TUBING PACK 2019031990 P243133 LATEX TUBING PACK 2019022190 P261569 PACK BIOPSY 2019021490 P392929 BMT-LACERATION PACK 2018121790 P429589A TRAY BONE MARRO ASC LTX SAFE 2019012590 P734457 SUTURE REMOVAL PACK LATEX SAFE 2019031990 P751651A BIOPSY PROCEDURE PACK 2019020890 P758486 PVP PREP PACK 2019041590 P758486 PVP PREP PACK 2019031990 P922260 ALCOHOL PREP PACK 2019041580 P928310 WET PREP TRAY 2019050690 P928310 WET PREP TRAY 2019031590 P948416 LACERATION PACK 2018110990 P966455A BREAST BIOPSY PACK-LF 2018122790

Why it was recalled

Incomplete seals on the sterile package may compromise the sterility

Root cause (FDA determination)

Packaging process control

Action the firm took

Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide Foreign: GHANA

Timeline

Recall initiated: 2019-12-11
Terminated: 2020-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178991. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.