FDA-Device2014-09-10Class I
CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) TUBE SUCTION CONNECT. ~"X 12' (1) TIP CAUTERY POLISHER (1) PENCIL CAUTERY ROCKER SWITCH (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) MAYO STAND COVER REINFORCED (10) LAP SPONGES
Customed, Inc
Hazard
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Sold states
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Affected count
16 lots; 1784 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) TUBE SUCTION CONNECT. ~"X 12' (1) TIP CAUTERY POLISHER (1) PENCIL CAUTERY ROCKER SWITCH (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) MAYO STAND COVER REINFORCED (10) LAP SPONGES PREWASH 18" X 18" XRD (1) BAG GLASSINE (2) SURGICAL BLADE #10 STAINLESS STEEL (1) EAR ULCER SYRINGE 2oz. (2) LIGHT GLOVE (1) BOWL UTILITY 16oz (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41 " X 58" SMS (1) ELECTRODE DUAL DEPRES./GROUNDPAD EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2359-2014Don't want to check this manually?
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