Z-1464-05

Banana Peel™ Sheaths BP/14/15 Catalog Number: 20-609

Name: Z-1464-05 Banana Peel™ Sheaths BP/14/15 Catalog Number: 20-609
Creator: Boston Scientific Corporation
Published: 2005-07-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-07-22 / Terminated

FDA source

Boston Scientific Corporation began a recall of Banana Peel™ Sheaths BP/14/15 Catalog Number: 20-609 on 2005-07-22. The reason FDA records is "The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1464-05
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-09-02
Terminated: 2007-06-20
Recalling firm: Boston Scientific Corporation
Product: Banana Peel™ Sheaths BP/14/15 Catalog Number: 20-609
Product code: KOB Catheter, Suprapubic (And Accessories)
Reason for recall: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
FDA root cause: Other
Action: Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.
Distribution: Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
Product codes and lots: Lot numbers: 6369319 6392604 6412087 6440250 6458182 6502513 6525652 6537822 6552545 6585322 6599018 6620745 6646571 6661841 6697321 6722536 6774278 6803135 6823846 6844314 6854850 6938751 6956397 6973991 7012895 7042711 7069901 7088270 7105143 7196764 7235415 7358084 7382687 7401686 7456767 7469359 7495157 7552030 7571547 7596737 7630036 7639884 7739648

Product code KOB

K961219Class IIPercutaneous Introducer SystemBoston Scientific Corp / cleared 1996-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-06. View this recall on fda.gov (opens on fda.gov)