International Biophysics Corp.: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

Agency Publication Date: August 19, 2015

Affected Products

Product: IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.

033115-3445

Product: IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

042415-3488, 022515-3372, 02215-3374, 022515-3372, 022515-3371, 022515-3373, 022515-3382, 022515-3383, 022515-3384, 022515-3385, 022515-3386, 040615-3452, 040615-3453, 040615-3449, 040615-3450, 040615-3451, 040615-3448, 040615-3447, 050815-3510, 050815-3509, 050815-3511, 050815-3512, 052715-3602, 060315-3603, 031215-3412, 022515-3387, 022515-3388, 033015-3442, 042415-3488

Product: IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.

031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71911

Status: Resolved

Manufacturer: International Biophysics Corp.

Manufactured In: United States

Units Affected: 3 products (100 units; 10,330 units; 771 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

033115-3445