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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:127056

Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek¿ pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle

Official recall number

Z-1708-2014

Evidence summary

Product code
NEW
Recall status
Terminated
Event initiated
April 23, 2014
Root cause
Employee error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1708-2014