Polysorb CL-250-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521040397), received between Nov 30, 2018 and Nov 30, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER DURING A PROCEDURE, IT WAS STATED THAT SIX(6) PRODUCTS WERE INCLUDED IN A PACKAGE WHICH WAS SUPPOSED TO HAVE FIVE(5) PRODUCTS. WHEN COUNTING THE NEEDLE AT THE END OF THE PROCEDURE, THERE WAS ONE MORE THAN USUAL, JUST IN CASE, X - RAY FILMING WAS PERFORMED, AND THERE WAS NO NEEDLE LEFT INSIDE THE PATIENT¿S CAVITY, SO IT WAS SUSPECTED THAT THERE WERE 6 PRODUCTS IN THE PACKAGE AS MENTIONED ABOVE. BECAUSE TWO LOT NO. WAS USED IN THE SAME CASE, IT COULD NOT BE CONFIRMED THAT WHICH LOT NO. HAD 6 PRODUCTS. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8120389 ↗
• InjuryNov 30, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER DURING A PROCEDURE, IT WAS STATED THAT SIX (6) PRODUCTS WERE INCLUDED IN A PACKAGE WHICH WAS SUPPOSED TO HAVE FIVE (5) PRODUCTS. WHEN COUNTING THE NEEDLE AT THE END OF THE PROCEDURE, THERE WAS ONE MORE THAN USUAL, JUST IN CASE, X - RAY FILMING WAS PERFORMED, AND THERE WAS NO NEEDLE LEFT INSIDE THE PATIENT¿S CAVITY, SO IT WAS SUSPECTED THAT THERE WERE 6 PRODUCTS IN THE PACKAGE AS MENTIONED ABOVE. BECAUSE TWO LOT NO. WERE USED IN THE SAME CASE, IT COULD NOT BE CONFIRMED THAT WHICH LOT NO. HAD 6 PRODUCTS. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 8120370 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI