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FDA Medical Device Recalls (openFDA)

Dow Corning Corp.: Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).

Recall number
Z-0029-04
Recalling firm
Dow Corning Corp.
Product
Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
Status
Terminated
Initiated
2003-09-05
Posted
2003-10-15
Terminated
2004-02-11
Reason
May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
Root cause
Other
Action
Customers were notified via phone call and by letter dated September 5, 2003. Customer were asked to return unused materials.
Quantity
2300
Distribution
United States.
Lot, serial or model codes
material number 3242901; lots 0001531727, 001583486 and 0001671243. material number 3242897; lot 0001604743.
510(k) numbers
not on file
PMA numbers
not on file
Product code
not on file
Firm FEI
1824893
Firm city
Hemlock
Firm state
MI
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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