Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1) SKIN MARKER WITH RULER (1) TUBE SUCTION CONNECT Y4" X 12' ( 1) CAST PADDING SOFT ROLL 4" X 4yds (10) GAUZE SPONGE 4" X 4" 16PLY ( 1) MERLING SKIN PREP APPLIC 39ML (1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFO
Product Description
Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1) SKIN MARKER WITH RULER (1) TUBE SUCTION CONNECT Y4" X 12' ( 1) CAST PADDING SOFT ROLL 4" X 4yds (10) GAUZE SPONGE 4" X 4" 16PLY ( 1) MERLING SKIN PREP APPLIC 39ML (1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50" X 90" (2) DRAPE SHEET 42" X 55" ( 1) STOCKINETTE 9" x 48" (1) CAUTERY PENCIL ROCKER SWITCH (2) LITE GLOVE ( 1) BANDAGE ESMARK 6" X 9yds ( 1) SHEET EXTREMITY ABS SMS 125" X 85" ( 1) UTILITY BOWL QUART 32oz Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Reason for Recall
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.
Details
- Recalling Firm
- Customed, Inc
- Units Affected
- 6 lots (272 packed units, multiple units per lot)
- Distribution
- 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.
- Location
- Fajardo, PR
Frequently Asked Questions
What product was recalled? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Related Recalls
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11