Bard Access Systems, Inc Site-Rite Sterile Needle Guide Kit - 18 gauge Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Site-Rite Sterile Needle Guide Kit - 18 gauge
Brand
Bard Access Systems, Inc
Lot Codes / Batch Numbers
Product Code 9001C0212. Lot numbers: 61208, 61233, 61258, 61287, 61308, 63189, 63220, 63225, 63263, 63305, 63338, 63360, 63383, 63402, 63414, 63442, 63472, 63515, 63530, 63564, 63597, 63646, 63720, 63766, 63783, 63817, 63845, 63875, 63924, 63953, 63991, 64056, 64063, 64125, 64164, 64191, 64258, 64261, 64269, 64330, 64364, 64401, 64420, 64433, 64448, 64452, 64514, 64652.
Products Sold
Product Code 9001C0212. Lot numbers: 61208, 61233, 61258, 61287, 61308, 63189, 63220, 63225, 63263, 63305, 63338, 63360, 63383, 63402, 63414, 63442, 63472, 63515, 63530, 63564, 63597, 63646, 63720, 63766, 63783, 63817, 63845, 63875, 63924, 63953, 63991, 64056, 64063, 64125, 64164, 64191, 64258, 64261, 64269, 64330, 64364, 64401, 64420, 64433, 64448, 64452, 64514, 64652.
Bard Access Systems, Inc is recalling Site-Rite Sterile Needle Guide Kit - 18 gauge due to Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.
Recommended Action
Per FDA guidance
All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.
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