Medical Device Recall: Z-0027-05

FDA Recalls dataset · Firm: Bioteque America Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-02-24 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0027-05.

Recall Res Number
Z-0027-05
Recalling Firm / Manufacturer
Bioteque America Inc
FEI Number
1000121341
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-02-24
Date Posted
2005-03-23
Date Terminated
2005-06-14
Product Code
N/A
Event Number
31276
Product Quantity
115 units
Product Description Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
Reason for Recall product is marketed without a 510(k)
Action Details The recalling firm telephoned the distributors and sales representatives on 2/23/05 informing them of the problem and the need to return the product. As a follow up to the telephone call, a recall letter dated 2/24/05 was issued to the distributors.
Distribution Pattern The products were shipped to distributors in OH and MI. The product was also provided to sales representatives.
Code Information / Serial Numbers Lot number 741105 exp 11/07

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