Boston Scientific Corp Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lot 8955327.
Products Sold
Lot 8955327.
Boston Scientific Corp is recalling Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog due to Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.
Recommended Action
Per FDA guidance
Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026